Manufacturing Technical Operations

• Lead high-complexity deviation investigations, including triage, data mining, GEMBA walks, and coordination with multidisciplinary SMEs.
• Drive advanced root cause analysis using structured methodologies (5-Why, Ishikawa, KT, GEMBA) to identify systemic issues and prevent recurrence.
• Own and execute complex CAPAs, ensuring robust effectiveness checks, cross-functional alignment, and sustainable long-term solutions.
• Initiate and guide Change Control records, ensuring accurate impact assessments, risk evaluations, and implementation strategies.
• Lead Analytical and QC investigations, including method performance review, data trending, and identification of quality risks.
• Ensure all quality records meet internal, regulatory, and industry standards for completeness, accuracy, and timeliness.
• Serve as a senior technical authority during internal audits, external inspections, and regulatory interactions.
• Partner with Manufacturing, QC, QA, MS&T, Engineering, and Supply Chain to resolve complex issues and strengthen process robustness.
• Identify patterns and recurring deviations, leading cross-functional initiatives to reduce variability and improve manufacturing reliability.
• Mentor junior and mid-level investigators, providing coaching on investigation strategy, documentation quality, and compliance expectations.

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Project Management, or related field.

• 10+ years of experience in pharmaceutical, biotechnology, cell therapy, or regulated manufacturing environment.
• Proven ability to independently lead high-complexity investigations and CAPAs in a fast-paced environment.
• Deep understanding of cGMP, FDA/EMA regulations, and quality systems.
• Extensive experience with electronic Quality Management Systems (eQMS).
• Exceptional analytical, problem-solving, and technical writing skills.
• Strong leadership presence with the ability to influence and guide cross-functional teams.
• Demonstrated ability to manage multiple high-visibility records simultaneously while meeting aggressive timelines.

Preferred Skills

• Experience in cell therapy, biologics, aseptic processing, or advanced therapy manufacturing.
• Proficiency with MES, LIMS, TrackWise, or similar systems.
• Formal training in advanced RCA methodologies (Kepner-Tregoe, Ishikawa, 5-Why).
• Experience mentoring and developing investigation talent.

• 12-month contract with possible extension
• Administrative shift
• Overtime availability