Lead Quality Validation Engineer

United Pharma; New York (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

United Pharma is seeking a Lead QAV Specialist to provide QA oversight for Commissioning, Qualification, and Validation activities at our GMP manufacturing facility and QC laboratories. The role focuses on ensuring cGMP compliance across validation master plans, project validation, and related qualification activities.

You will lead QA for CQV changes, manage the QAV team and CMMS collaborations, and support risk assessments and CAPAs tied to commissioning and qualification efforts.

Qualifications

• Bachelor's degree and 5+ years related experience; or Master’s with 3+ years; or PhD with up to 1 year.
• Strong knowledge of 21 CFR, ICH, EU regulations.
• Experience with Cell and Gene Therapy manufacturing is a plus.
• Experience with facility commissioning/qualification preferred.

Responsibilities

• Leads QA partnership for commissioning, qualification, and validation activities for GMP facility and QC laboratories.
• Oversees QA events related to validation and engineering operations (equipment upgrades, deviations, CAPAs).
• Authorizes CQV changes via impact assessments and QA approvals.
• Oversees CMMS by collaborating with Engineering and Lab to evaluate QA impact of requests.
• Interact with project teams to develop schedules, track milestones, and maintain timelines.
• Provide administration support for Kneat electronic validation system as needed.
• Lead QA oversight for periodic review and requalification activities.
• Manage QAV team including FTEs and contractors.
• Support Equipment Relocation program QA activities as needed.

Skills

QA oversight

cGMP knowledge

Risk assessment

Project coordination

Technical writing

Education

Bachelor's degree

Master's degree

Tools

Kneat

Veeva

Blue Mountain CMMS

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Lead QAV Specialist to provide QA oversight for Commissioning, Qualification, and Validation activities. In this role the Lead will be responsible for managing cGMP compliance from a Quality Assurance prospective of validation master plans, project validation plans, facility commissioning/qualification, utility commissioning/qualification, process equipment qualification, and lab equipment and instrument qualification. In addition, this position will support all risk assessments, technical reports, change controls, deviations and CAPAs related to commissioning, qualification, and validation activities. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals within the QAV group.

Here’s What You’ll Do

• Leads QA partnership for operational activities for Engineering groups (i.e. commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories). Recognized as quality expert for these programs and acts as direct escalation pathway for teams.
• Leads QA oversight of quality events for ongoing validation and engineering operations (equipment upgrades, deviations, and related CAPAs). Scope inclusive of manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Independently evaluates CQV change controls by authoring impact assessments and provides QA support and approval for associated CQV activities.
• Leads QA oversight for CMMS, collaborates with Engineering and Lab and Site Services to evaluate Quality impact for database modification requests.
• Liaise with project teams to develop project schedules, elevate issues, track milestones, and ensure adherence to program timelines.
• Potential to provide administration support for Kneat electronic validation system.
• Leads QA oversight and support for periodic review and requalification activities.
• Manage team of QAV personnel including both FTE and contractor resources
• QA SME for Equipment Relocation program, supports all relocation activities that arise due to ongoing manufacturing needs.

Requirements

• Bachelor’s degree and at least 5 years of related experience; or Master’s degree with at least 3 years of related experience; or a PhD with up to 1 year of related experience.
• Strong knowledge of 21 CFR, ICH, EU regulations
• Prior experience in Cell and Gene Therapy manufacturing a plus.
• Experience in new facility commissioning and qualification preferred.
• Experience with Blue Mountain CMMS system desired.
• Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint, Kneat, Veeva, Blue Mountain CMMS)
• Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
• A team player, who listens effectively and invites response and discussion.
• A collaborator who communicates in an open, clear, complete, timely and consistent manner.