Sobre este puesto de 6446 - Senior CQV Engineer / Senior Validation Engineer en Verista, Inc.
Description
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Job Overview: We are seeking a Senior CQV Engineer to lead C&Q deliverables and field coordination for facilities, utilities, HVAC, cleanrooms, process gases, room qualification, and building-system interfaces. This role needs a field-capable facilities/utilities validation lead who can work across construction turnover, walkdowns, commissioning evidence, PSSR, green tag, blue tag, IOQ/PQ where applicable, and final qualification reporting.
Senior Validation Engineer Responsibilities:
- Own utility/facility/room C&Q deliverables
- Coordinate TOP review, PSSR/Green Tag/Blue Tag evidence, room qualification interfaces, utility stability readiness, and commissioning summary reports
- Own assigned facility, utility, and room commissioning/qualification deliverables: design review, DQ/QRA/traceability where applicable, commissioning protocol/report, IOQ/PQ as required, QSR, green tag, blue tag, and turnover evidence
- Coordinate PSSR readiness, TOP review, walkdowns, test vendor scheduling, room qualification interfaces, utility stability readiness, and commissioning summary reports
- Track discrepancies, punch items, calibration needs, external certification/testing gaps, and field evidence issues through closeout
- Feed status and blockers into PM/document control trackers and coordinate with process/aseptic system leads when utility or room readiness affects equipment execution
- Must coordinate with construction manager, engineering/design, utilities/facilities, vendors, certifiers/testing firms, operations, quality, and system leads
Job Requirements:
- Bachelor’s Degree or equivalent required
- 8-12+ years facility/utilities CQV in GMP manufacturing, preferably biologics, sterile, cell/gene therapy, vaccine, or pharmaceutical capital projects
- Hands-on HVAC/cleanroom qualification experience: AHUs, HEPA filters, pressure cascades, airflow visualization/interface, room classification, environmental monitoring coordination, and cleanroom test vendor management
- Utilities experience with process gases, clean/plant air, oxygen, carbon dioxide, steam, chilled water, process tempered water, liquid nitrogen, process waste, utility panels, pass-through boxes, and UPS/fire/security interfaces
- Strong construction turnover package review and field walkdown background; can identify missing evidence before it delays green tag/blue tag or qualification execution
- Experience with ISPE Baseline Guides, ASTM E2500, and GMP regulations
- Strong communication, planning, and leadership skills
This role requires the ability to be on-site, full-time in Devens, MA.
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
Benefits
Why Choose Verista?
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
