Job Details

Staff QA Engineer

The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory compliance. This senior-level position involves leadership, mentorship, and high-level coordination of validation processes across multiple sites. Typical work hours are Monday - Friday from 8a - 5p, but the role also requires this individual to have on-call weekends based on a predefined schedule for urgent off-hours questions.

Key Responsibilities:

• Lead QA validation activities related to Facilities, Utilities, Engineering, Quality Control, and Operational equipment.
• Provide strategic quality oversight of facility and equipment commissioning and other activities.
• Review and approve: Equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols and reports. Validation related deviations and discrepancies. Process Validation (PV), Cleaning Validation, and Computer System related protocols and reports.
• Lead QA support for risk assessment, FMEA, and change controls governing validation related activity.
• Coordinate and lead validation activities with multi-functional team members to ensure efficiency and compliance with regulations.
• Develop and maintain a safety and quality culture.
• Mentor and train junior QAV Engineers.
• Drive continuous improvement initiatives in validation processes.

Qualifications:

• BS/BA in a scientific or related field required, preferably in Biology/Chemistry or Engineering. Advanced degree preferred.
• 5+ years of experience in Quality and/or Validation.
• 7+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience strongly preferred.
• Proven ability to lead and mentor multi-functional teams.
• Strong leadership skills and ability to work within a matrix organization.
• Ability to support and lead multi-functional and multi-site initiatives involving integration.
• Excellent written and oral communication skills; ability to communicate effectively with Senior Leadership and all levels below.
• Ability to prioritize, align and simplify, demonstrate enthusiasm, take accountability and drive for results.
• In-depth knowledge of cGMPs, technical writing, data management collection, and analysis.
• Exceptional interpersonal skills, including teamwork, facilitation, and negotiation.
• Ability to work independently, with a pro-active mentality to mitigate risk.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!