EPM Scientific
Quality Engineer, Validation Manager
EPM Scientific, Irvine, California, United States, 92713
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Base pay range
$100,000.00/yr - $140,000.00/yr Direct message the job poster from EPM Scientific Recruitment Consultant at EPM Scientific
I'm currently working with an established Pharma company that has been keen on innovation for the last 50 years. Despite having the first FDA approved injection of its kind, growth is still the name of the game. It's time to continue to build out their Quality leadership team. Responsibilities: Lead and manage the Validation and Quality Engineering teams responsible for qualification and validation activities across facilities, utilities, equipment, and processes. Oversee all commissioning, qualification, and validation (CQV) activities, including URS development, IQ, OQ, PQ, engineering studies, risk assessments, and summary reporting. Develop and maintain the site Validation Master Plan (VMP), ensuring alignment with current regulatory guidance and industry best practices. Provide technical support and subject matter expertise during regulatory inspections, client audits, and internal quality reviews. The ideal candidate brings: A strong technical foundation in validation and aseptic processing Deep understanding of regulatory compliance Proven leadership and project management capabilities Experience with isolators and RABS (highly preferred) Competitive comp package: Bonus This position involves close collaboration with cross-functional teams in Manufacturing, Engineering, and Quality to ensure validation activities are executed efficiently, documented thoroughly, and maintained in a state of compliance. This position plays a key role in ensuring that facilities, utilities, equipment, and processes operate in compliance with cGMP and regulatory expectations. Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
Referrals increase your chances of interviewing at EPM Scientific by 2x Get notified about new Quality Engineer jobs in
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$100,000.00/yr - $140,000.00/yr Direct message the job poster from EPM Scientific Recruitment Consultant at EPM Scientific
I'm currently working with an established Pharma company that has been keen on innovation for the last 50 years. Despite having the first FDA approved injection of its kind, growth is still the name of the game. It's time to continue to build out their Quality leadership team. Responsibilities: Lead and manage the Validation and Quality Engineering teams responsible for qualification and validation activities across facilities, utilities, equipment, and processes. Oversee all commissioning, qualification, and validation (CQV) activities, including URS development, IQ, OQ, PQ, engineering studies, risk assessments, and summary reporting. Develop and maintain the site Validation Master Plan (VMP), ensuring alignment with current regulatory guidance and industry best practices. Provide technical support and subject matter expertise during regulatory inspections, client audits, and internal quality reviews. The ideal candidate brings: A strong technical foundation in validation and aseptic processing Deep understanding of regulatory compliance Proven leadership and project management capabilities Experience with isolators and RABS (highly preferred) Competitive comp package: Bonus This position involves close collaboration with cross-functional teams in Manufacturing, Engineering, and Quality to ensure validation activities are executed efficiently, documented thoroughly, and maintained in a state of compliance. This position plays a key role in ensuring that facilities, utilities, equipment, and processes operate in compliance with cGMP and regulatory expectations. Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
Referrals increase your chances of interviewing at EPM Scientific by 2x Get notified about new Quality Engineer jobs in
Irvine, CA . Irvine, CA $106,000.00-$141,300.00 3 days ago Santa Ana, CA $80,000.00-$110,000.00 6 days ago Long Beach, CA $87,000.00-$111,100.00 2 weeks ago Newport Beach, CA $70,000.00-$110,000.00 1 year ago Irvine, CA $95,737.50-$140,415.00 5 days ago Santa Ana, CA $80,000.00-$95,000.00 1 month ago Santa Ana, CA $75,000.00-$90,000.00 6 days ago Santa Ana, CA $80,000.00-$100,000.00 1 week ago Long Beach, CA $100,000.00-$120,000.00 6 days ago Santa Fe Springs, CA $70,000.00-$100,000.00 21 hours ago Huntington Beach, CA $25.00-$25.00 1 week ago Santa Ana, CA $100,000.00-$100,000.00 4 days ago Irvine, CA $66,000.00-$82,500.00 3 weeks ago Irvine, CA $71,000.00-$95,000.00 6 days ago Irvine, CA $96,000.00-$186,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr