Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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!
Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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