Genezen
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The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
Genezen is hiring for an Automation Engineer in our Lexington, MA office. The position will be hired as an Engineer I, II or III dependent on experience level of the successful candidate. The Automation Engineer is responsible for the administration of all facilities and process automation.
JOB RESPONSIBILITIES
- Provides automation support and troubleshooting services to Genezen’s operational groups.
- Supports design, implementation, and commissioning/qualification of new automation systems.
- Provides budgetary and schedule estimates for all automation related projects.
- Leads automation specific projects to modify/improve equipment, facilities, and/or process controls with supervisory oversight.
- Provides technical support and analysis for the resolution of deviations, investigations, and process issues.
- Develops test scripts, automation procedures, and specifications.
- Candidate will be required to carry a cellular phone and be on call to support manufacturing operations.
SPECIAL WORK REQUIREMENTS
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
|
EDUCATION/CERTIFCATIONS/LICENSES |
|
|
B.S in Engineering, Computer Science, or related field. |
Essential |
| ON-THE-JOB EXPERIENCE | |
| 2-8+ years relevant experience | Essential |
| SKILLS/ABILITIES | |
| Troubleshoot PLC and SCADA systems | Desired |
| Experience with Allen-Bradley, Johnson Controls | Desired |
| Familiarity with cGMP operations and 21 CFR Part 11 regulations | Essential |
| Experience with pharmaceutical/biopharmaceutical equipment commissioning, validation, and performance monitoring. | Essential |
Compensation:
The compensation range for this position is $65,000-$130,000 dependent upon experience level of the successful candidate.
Work Environment
- Regularly sit for long periods of time
Movement
- Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
- Frequently lift and/or move up to 10 pounds
- Rarely lift and/or move up to 25 pounds
Vision
- Frequently utilize close vision and the ability to adjust focus
Communication
- Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
Ready to apply?
Apply to Genezen
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The incumbent is responsible for assisting in completion of all computer system validation project milestones. This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test validation procedures/protocols, and preparation of all relevant documentation in accordance with appropriate regulatory agency validation requirements, quality management system and current industry practices (includes standard operating procedures, technical reports and risk assessments).
ESSENTIAL JOB FUNCTIONS
- Develop moderately complex test protocols, provides on-site execution support, data analysis, and report generation for various installation, operational and performance qualification activities.
- Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry and regulatory guidance.
- Investigates / troubleshoots validation problems.
- Support and/or initiate investigations into protocol non-conformances and site deviations.
- Serve as initiator and owner of validation related change controls and corrective and preventative actions.
- Provides input to standard operating procedures related to validation practices.
- Support the implementation of validation programs (e.g., requalification).
- Represent the validation department at team meetings or projects.
- Performs periodic reviews and ongoing support of validated systems post Go-Live.
- Perform revalidation and change control validation related activities.
- Ability to apply complex system validation principles to work assignments.
- Responsible for executing and reviewing control systems validation activities including projects associated with BMS, CMS, and other automation upgrades.
- Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
- Assist validation activities of cross functional teams that include technical functions such as Quality Control, Information Systems, Manufacturing and QA Engineering.
SPECIAL WORK REQUIREMENTS
- Fully onsite position
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
|
EDUCATION/CERTIFCATIONS/LICENSES |
|
|
A minimum of a Bachelors degree in Engineering |
Essential |
|
ON-THE-JOB EXPERIENCE |
|
|
5+ years of validation experience |
Essential |
|
KNOWLEDGE, SKILLS AND EXPERIENCE |
|
|
The individual must possess strong written and oral communication skills: The ability to communicate with employees of all experience levels. |
Essential |
|
The ability to report on project activity in a clear and concise manner. |
Essential |
|
The ability to negotiate when necessary and compromise with other project team representatives to achieve project goals. |
Essential |
|
The ability to listen and respect fellow project team member’s ideas and opinions and work through conflict and disagreements. |
Essential |
|
GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity Guidance, ICH Q7A requirements, and GAMP 5. |
Essential |
|
Experience in thorough testing of applications, computerized systems, changes and implementations |
Essential |
|
Excellent written and oral communication to include accurate and legible documentation skills. |
Essential |
|
Ability to work independently in a fast-paced environment with a strong work ethic. |
Essential |
|
Must be able to sit or stand for prolonged periods of time. |
Essential |
|
Good knowledge and skills in engineering of Automation for HVAC/ Process Utility/Monitoring Building Management Systems. |
Essential |
Pay Range:
The annual salary range for this position based upon level hired is: $90,000-$130,000
Work Environment
- Regularly sit for long periods of time
Movement
- Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
- Frequently lift and/or move up to 10 pounds
- Rarely lift and/or move up to 25 pounds
Vision
- Frequently utilize close vision and the ability to adjust focus
Communication
- Frequently required to communicate by talking, hearing, using telephone and e-mail
Pay Range:
The annual salary range for this position based upon level hired is: $85,000-$130,000
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
Ready to apply?
Apply to Genezen
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
Provide maintenance, calibration, and technical support to the manufacturing process and facility equipment. Coordinate and perform testing and calibration on electrical, mechanical, and analytical equipment for conformance to established standards. Request purchase order requisitions for 3rd party maintenance requirements.
ESSENTIAL JOB FUNCTIONS
- Assist in creating/establishing a Maintenance and Calibration Program including recommendation of Maintenance and Calibration activities and frequencies based upon system/equipment assessments
- Plan, schedule, and perform planned and unplanned maintenance and calibration on process and facility equipment/utilities including but not limited to HVAC, freezers, cold rooms, bioreactors, filling systems, analytical testing instruments, and building management control systems
- Coordinate and support external calibration service providers
- Build relationships with customers, colleagues, and service partners to provide a collaborative approach to the operational management of lab spaces.
- Track and report on calibration status of all equipment/instruments in the facility
- Ensure timely completion of calibrations/preventive maintenance and compliant record keeping.
- Obtain required documentation and approval prior to creation of purchase order requisition for service requests to be completed by 3rd party vendors.
- After purchase order has been issued, ensure service delivery dates are correct and revise as necessary, per follow-up with suppliers and customers.
- Source, qualify, negotiate, and procure service contracts in support of lab operations.
- Ensure purchase requisitions are requisitions closed within 180 days and confirm that associated purchase orders are closed as well.
- Enter and maintain records in the Computerized Maintenance Management System (CMMS)
- Meet regularly with key stakeholders (lab staff, service partners, management) to identify, review and resolve issues in a timely manner and/or escalate as necessary.
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCE
- Associates Degree
- Bachelor's degree
- EET
- 3-5 years related Calibration/Metrology work experience
- Ability to understand user manuals/specifications, wiring diagrams, equipment Piping & Instrumentation Diagrams (P&ID), and Standard Operating Procedures (SOP)
- Mechanically inclined/knowledge of hand tools
- Proficient with advanced computer systems including the use of a CMMS
- Excellent interpersonal skills and communication skills with ability to act as a change agent
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment
- Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
- Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
- Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
- Occasionally exposed to extremely loud noise levels
- Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required
Movement
- Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
- Frequently lift and/or move up to 10 pounds
- Occasionally lift and/or move up to 25 pounds
Vision
- Frequently utilize close vision and the ability to adjust focus
Communication
- Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
Ready to apply?
Apply to Genezen
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The incumbent is responsible for assisting the Validation manager in completion of all project milestones. This includes installation, operational and performance qualification of equipment and utilities, environmental qualification, process validation, and preparation of all relevant documentation to meet regulatory requirements for new and existing products (includes standard operating procedures, technical reports and risk assessments). Duties require some knowledge in the pharma/biotech field.
**This position is onsite 5 days per week in our Lexington, MA office
JOB RESPONSIBILITIES
- Perform hands on execution of site Re-Qualifications on equipment, utilities, controlled temperature units, and Media Fills.
- Support efforts in developing remediation for follow-up and emergency requalification work.
- Familiarity with GE Kaye Validator and/or lives data acquisition systems.
- Generates validation protocols, executes protocols, completes data analysis and writes final reports.
- Perform calibrations on thermocouples with data loggers in a GMP/GXP environment.
- Participate in peer review and approval of validation documentation.
- Works in close collaboration with Manufacturing, Facilities, Supply Chain, Quality Control, and Quality Assurance teams to complete qualification responsibilities.
SPECIAL JOB REQUIREMENTS
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCE
|
EDUCATION / CERTIFICATIONS / LICENSES |
Essential/Desired |
|
AS degree or certificate in a science/technical field or a technical trade school. |
Desired |
|
ON-THE-JOB EXPERIENCE |
|
|
1+ years of relevant experience working in a regulated (cGMP preferred) environment. |
Essential |
|
SKILLS/ABILITIES |
|
|
Excellent oral and written communication skills. |
Essential |
|
Superior attention to detail and ability to multi-task and prioritize assignments. |
Essential |
|
Experience with and knowledge of metrology/calibration principles. |
Essential |
Pay Range:
The hourly compensation range for this position is $27/hr-$38/hr.
Work Environment
- Regularly sit for long periods of time
Movement
- Frequently required to stand, sit, use hands to finger, handle or feed; reach with hands and arms
- Occasionally required to walk, climb or balance, and stoop, kneel, crouch or crawl
Lifting
- Frequently lift and/or move up to 10 pounds
- Rarely lift and/or move up to 40 pounds
Vision
- Frequently utilize close vision and the ability to adjust focus
Communication
- Frequently required to communicate by talking, hearing, using telephone, and e-mail
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
Ready to apply?
Apply to Genezen