6245 - Solution Prep Principal CQV Engineer / Lead Validation Engineer

Solution Preparation Principal CQV Engineer / Lead Validation Engineer

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Responsibilities

Commissioning, Qualification & Validation

• Support commissioning, qualification, and validation (CQV) activities for solution preparation systems used in biopharmaceutical manufacturing.
• Author, review, and execute CQV lifecycle documentation including:
• Commissioning test protocols
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation summary reports
• Ensure validation documentation complies with cGMP regulations and internal quality procedures.
• Participate in system impact assessments, risk assessments, and validation planning activities.

Solution Preparation Process Support

• Provide technical support for solution preparation unit operations, including systems such as:
• Buffer preparation systems
• Media preparation systems
• Solution preparation tanks and mixing systems
• Single-use mixing systems
• Transfer and hold systems
• Support equipment startup and operational readiness for solution preparation processes.
• Afford assistance with troubleshooting and process verification during commissioning and qualification activities.

Vendor & Equipment Startup

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.
• Coordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.
• Participate in equipment startup, commissioning, and operational testing activities.

Cross-Functional Coordination

• Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.
• Afford assistance with deviation investigations, change control processes, and documentation updates.
• Ensure CQV activities align with project schedules and operational readiness milestones.

Digital Validation Systems

• Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.
• Maintain data integrity, traceability, and compliance within digital validation systems.

Requirements

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related technical field
• 10+ years of role specific experience
• Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments
• Hands-on experience with solution preparation, buffer prep, or media prep systems
• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)
• Ability to work independently while coordinating with cross-functional teams
• Strong technical documentation and communication skills
• Experience using digital validation platforms such as Kneat
• Experience supporting FAT/SAT, commissioning, and equipment startup
• Familiarity with single-use systems and biologics manufacturing processes
• Experience working within biologics or cell culture manufacturing facilities

Qualifications

Onsite job requirement in Apex, NC

Pay

National (US) Range: $107,800 - $168,011 USD

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

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