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# Manufacturing Technical Operations

- **Company:** BioPharma Consulting JAD Group
- **Location:** Boston, MA, United States
- **Experience:** Expert
- **Contract:** Temporary to permanent
- **Skills:** Data Mining, Laboratory Information Management Systems, Trackwise, Ishikawa
- **Published:** September 12, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=91d4e9ca92a65e0c

## About the Role

* 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.

## Description

* 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.


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