Commissioning Engineer

Commissioning Engineer at BioTalent Commissioning Engineer at BioTalent in Gaithersburg, Maryland Posted in 3 days ago.

Type:

full-time

Job Description:

Senior Validation Engineer (Pharmaceutical Manufacturing) Position Summary We are seeking a Senior Validation Engineer to lead and execute validation activities supporting GMP pharmaceutical manufacturing. This role is responsible for ensuring equipment, utilities, facilities, processes, and computerized systems meet regulatory requirements and operate in a validated state throughout their lifecycle. The ideal candidate is experienced in FDA/EMA regulated environments , thrives in cross-functional teams, and can independently drive complex validation projects. Key Responsibilities Validation Leadership Lead and execute validation lifecycle activities including: Commissioning & Qualification (C&Q) Equipment and Utility Qualification (IQ/OQ/PQ) Process Validation (PPQ/CPV) Cleaning Validation Computer System Validation (CSV) support Author, review, and approve validation deliverables: Validation Master Plans (VMPs) Risk Assessments (FMEA, RA, impact assessments) Protocols and reports (IQ, OQ, PQ, TMV, PV) Traceability matrices and discrepancy reports Ensure validation activities comply with: cGMP (21 CFR Parts 210/211) FDA, EMA, and ICH guidelines Data integrity (ALCOA+) Project & Cross-Functional Collaboration Serve as validation lead for capital projects, tech transfers, and new product introductions. Collaborate with Engineering, Manufacturing, QA, QC, Automation, and Regulatory Affairs. Provide validation strategy and risk-based approaches for new and existing systems. Support vendor FAT/SAT and commissioning activities. Lifecycle & Continuous Improvement Maintain validated state through: Change control assessments Periodic review programs Requalification strategies Deviation and CAPA investigations Identify and implement process improvements and efficiency gains. Mentor junior engineers and validation specialists. Compliance & Inspection Readiness Support internal and external audits and regulatory inspections. Defend validation strategy and documentation during inspections. Ensure documentation is inspection-ready at all times. Qualifications Education Bachelor's degree in Engineering, Life Sciences, or related field (required) Master's degree (preferred) Experience 5+ years of validation experience in pharmaceutical or biotech manufacturing Strong experience with: Equipment & utility qualification Process validation and tech transfer Risk-based validation approaches GMP documentation practices Technical Expertise Experience validating systems such as: Manufacturing equipment (mixers, reactors, fillers, packaging lines) Clean utilities (WFI, clean steam, compressed gases) HVAC and controlled environments Laboratory equipment Automated and computerized systems Regulatory Knowledge Strong understanding of: cGMP and GDP requirements

FDA & EMA

regulatory expectations

ICH Q8, Q9, Q10 ISPE

Baseline Guides & GAMP 5 Data Integrity principles (ALCOA+) Key Competencies Excellent technical writing and documentation skills Strong project management and organizational skills Ability to lead complex projects independently Analytical problem-solving mindset Effective communication across technical and non-technical teams Preferred Experience Experience in aseptic or sterile manufacturing Experience with serialization or packaging validation Six Sigma / Lean certification Experience supporting regulatory inspections What Success Looks Like Projects delivered on time and inspection-ready Robust, risk-based validation strategies implemented Continuous compliance maintained across validated systems Strong collaboration and mentorship within the organization