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Sobre esta vaga de Manager, Process Engineering na Pfizer

Pfizer · Presencial · United States - North Carolina - Sanford


Use Your Power for Purpose

Our dedicated manufacturing support team ensures that all manufacturing activities at Sanford are conducted with the highest level of compliance and quality. By embracing challenges, imagining new possibilities, and taking decisive action, you will play a crucial role in accelerating the delivery of medicines to the world. Your efforts will help bring essential treatments to those in need faster than ever before, making a significant impact on global health. Join us in this mission to innovate and overcome obstacles, ensuring that life-saving medications are always within reach for those who depend on them.


What You Will Achieve

In this role you lead a Process Engineering team, which includes all activities related to proper staffing, performance management, training curricular assignment/maintenance and growth/development. Two roles available, one supports Chemistry Trains 1 and 2, the other supporting Train 3.


Role Summary:

Leads a Process Engineering team, which includes all activities related to proper staffing, performance management, training curricular assignment/ maintenance and growth/development. Manages technological and financial resources.

Services include review of process requirements and evaluation of equipment and systems to ensure deliverables meet or exceed process specifications and manufacturing requirements.  Will provide technical guidance and systems and automation training to production colleagues. Provides process engineering support of cGMP clinical and /or commercial manufacturing processes and equipment working with the Manufacturing Area Leads.

Analyzes equipment and process issues and supports related investigations. 

Advise management of non-conformance issues and opportunities for continuous improvement via data trend analysis, interpretation of data, gap analysis and implementation of corrective activities. 

Provides input on decisions for SOP’s, batch records, forms or other cGMP related documents developed or revised to support continuous improvement efforts, investigation corrective actions, process descriptions, manufacturing operations, automation control (DeltaV, etc.) and regulatory audit commitments.

Evaluates new processes for clinical or commercial production in mAb or vaccine manufacturing facilities. This can include facility fit analysis and direct input into tech transfer documentation. This may also include new capital equipment purchases and the implementation of new technologies.

Conducts all activities and makes decisions in accordance with Company policies & SOPs, Pfizer Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc. 


Role Responsibilities:

Individual Accountabilities:


  • Accountable for the general oversight of a Process Engineering team
  • Provides direction for goal setting and performs semi annual goal assessments
  • Cultivates a culture where improvement and learning are foundational elements of “how we do business”
  • SME of process, equipment, and automation change requests for prioritization as well as support regulatory inspections.
  • Requires general knowledge of scientific principles, technical knowledge of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on assigned production area.
  • Role will entail commitment ownership and investigations support as needed.
  • Spends time on the production floor as needed to proactively identify and drives implementation of improved efficiencies and ensures that product quality is maintained through critical phases of production.
  • Responsible for technical problem diagnosis in support of root cause determination.
  • Capable of identifying technical problems and solving them as needed.
  • Ability to analyze operational process issues and automation challenges to recommend / initiate appropriate corrective and preventative actions. 
  • Acts as a departmental liaison with primary site support groups such as commercial technical services, quality control, quality assurance, and SEM to drive Operations support strategy.
  • Serves as primary manufacturing support  for clinical  technical input and facility fit discussions.
  • Ensure equipment requirements can meet processing needs.
  • Contributes/ownership of user requirements, validation documentation, P&IDs, PFDs and tech transfer documentation.
  • Technical review/ownership of applicable documentation (i.e.  TTDs, MBRs, SOPs, etc.)
  • Support development / deployment / troubleshooting of electronic batch records.

Shared Accountabilities:


  • Works with sending site, Engineering, Automation, QA, commercial tech services, etc. to ensure robust manufacturing processes
  • Works with PCS to develop detailed automation design(s) and specifications
  • Coordinates activities necessary to test and qualify equipment and automation changes in the production environment
  • Coordinate activities with PCS to resolve automation issues and changes
  • Coordinate activities with maintenance to resolve mechanical issues

Technical Competencies


  • Expertise of scientific principles, operational and design aspects of production equipment, automation control systems, and processing requirements. 
  • Capable of detecting and troubleshooting technical issues on the production floor. 
  • Expertise of required processing unit operations and control systems within assigned production area.   
  • Knowledge of distributed control systems (Delta, FactoryTalk Batch, etc.), single-use technology and tech transfer processes.

Behavioral Competencies


  • Strong leadership skills including team facilitation, training, and motivation
  • Capable of identifying technical problems and solving them with minimal guidance
  • Capable of facilitating collaboration with different functional stakeholders and develop appropriate action plans.
  • Demonstrated ability to interact effectively with colleagues at all levels of the organization.
  • Capable of working independently and multi-tasking.
  • Flexible to changing priorities, meeting deadlines, and working well under pressure.
  • Lead and manage duties in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies, procedures, and compliance initiatives.
  • Management of multiple projects/initiatives simultaneously.
  • Strong organizational, time management and communication skills.
  • Critical thinking/decision making ability.


 

Here Is What You Need (Minimum Requirements)

  • Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience 
  • Relevant experience in the pharmaceutical industry
  • Previous People Leader Experience

Bonus Points If You Have (Preferred Requirements)


  • Experience with DS conjugation manufacturing, manual and automated equipment processing, and knowledge of lyophilization and UFDF processes.  
  • Experience with clinical and commercial processing requirements.



OTHER JOB DETAILS

 

Last Date to Apply for Job: 10/30/26
Work Location Assignment: On Premise

 

 

The annual base salary for this position ranges from $116,000.00 to $193,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

 

 

 

 

 

 

 

 

Relocation assistance may be available based on business needs and/or eligibility.

 

 

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

 

 

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

 

 

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.  This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

 

 

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

 

 

Global Operations

 

 

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