Lead CQV Engineer (Upstream Manufacturing) / Lead Project Engineer
Job Overview
A leading organization in the life sciences industry is seeking a seasoned CQV (Commissioning, Qualification, and Validation) Lead to manage CQV activities for a new greenfield commercial drug product facility. This role focuses on overseeing upstream manufacturing processes, including single-use bioreactors, large-scale stainless steel bioreactors, and centrifuges, ensuring full CQV delivery from inoculation through harvest.
Key Responsibilities:
Lead and manage all aspects of CQV activities for upstream manufacturing systems.
Oversee the commissioning, qualification, and validation of equipment such as bioreactors (both single-use and large-scale stainless steel) and centrifuges.
Ensure full end-to-end CQV compliance across all systems.
Develop and execute FAT, SAT, IOQ, and CSV protocols for various GMP equipment.
Coordinate across departments to ensure smooth execution of CQV procedures and documentation.
Required Qualifications:
10+ years of experience in CQV activities within GMP-regulated environments.
Strong background in commissioning and validation for upstream systems in a biotech or pharmaceutical setting.
Proven ability to author and execute critical technical protocols, including FAT, SAT, IOQ, and CSV.
Experience with GMP and Good Documentation Practices (GDP).
High-level proficiency in technical documentation using Microsoft Word, including editing large documents, creating tables, and tracking changes.
Basic skills in Excel and PowerPoint for creating and presenting reports and data.
Excellent communication skills, both written and verbal, with the ability to liaise effectively with various stakeholders at different levels within an organization.
Detail-oriented, with strong organizational skills to handle complex projects independently.
Position Location:
This is an onsite position, and the successful candidate must be available to work at the designated location.
Salary Range:
The salary for this position ranges from $107,800 to $177,093 USD depending on factors such as experience, location, and qualifications. Note that this range is subject to change based on market conditions and internal considerations.
Benefits Offered:
Competitive salary plus performance-based incentives.
Comprehensive benefits package, including medical, dental, and vision insurance.
Paid Life, Short-Term, and Long-Term Disability Insurance.
Health Savings Account (HSA) and Flexible Spending Accounts (FSA).
401(k) plan with employer matching.
Paid Time Off (PTO) and holiday pay, including rollover options.
Tuition reimbursement program.
Employee recognition programs and team-building social activities.
Paid parental leave and bereavement support.
Supplemental insurance options for life, hospital, and critical illness.
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