Manufacturing Investigation Manager

SHARP STERILE MANUFACTURING LLC•Lee, MA

13h

About The Position

The Manufacturing Investigation Manager, Manufacturing is responsible for leading and overseeing investigations associated with manufacturing deviations, batch discrepancies, equipment failures, environmental events, out‑of‑trend (OOT) issues, and other GMP‑related incidents. This role ensures investigations are scientifically sound, compliant with cGMP requirements, and completed within defined timelines to support reliable batch release and ongoing manufacturing excellence

Requirements

5+ years of experience in the pharmaceutical, biotech, or medical device industry.
Direct experience in GMP manufacturing, quality assurance, or technical operations strongly preferred.
Demonstrated experience leading manufacturing investigations and developing CAPAs.
Bachelor’s degree in Science, Engineering, Pharmacy, Chemistry, Biology, or a related technical field required.
Familiarity with U.S. FDA, EU Annex-1 and other regulations and guidance
Strong investigative skills, preferably familiar with Root Cause Analysis methods
Shown expertise with audits and client-facing roles
Outstanding technical writing skills
cGMP Compliance
Strong sense of diplomacy and assertiveness
Quality Judgement
Effective time management and prioritization skills
Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters
Outstanding attention to detail and organizational skills
Self-starter, mature, independent and conscientious
Ability to work in a fast-paced environment under pressure
Able to multi-task
Results-oriented
Ability to maintain a high degree of confidentiality
Requires discretion and independent judgment
Detailed knowledge of aseptic processing and practical experience in an active aseptic manufacturing operation
Knowledge of aseptic process simulations (media fills)
Ability to sit for prolonged periods of time
Ability to stand for prolonged periods of time
Ability to lift up to 20lbs

Responsibilities

Lead end‑to‑end investigations for manufacturing deviations, processing issues, equipment malfunctions, material/ingredient discrepancies, and environmental/utility excursions.
Partner with Manufacturing Operations, Engineering, MS&T, QC, Validation, Supply Chain, and QA to gather data, conduct fact‑finding, and assess operational impacts.
Ensure investigations are objective, evidence‑based, and compliant with internal quality procedures and global regulatory requirements (FDA 21 CFR Parts 210–211, EU GMP, ICH Q7/Q10).
Apply structured RCA methods, including: 5 Whys, Fishbone (Ishikawa) diagrams, Process mapping and equipment troubleshooting, and other methods.
Ensure clear differentiation between root causes, contributing factors, and gaps in controls.
Collaborate with process owners to design meaningful corrective and preventive actions (CAPAs) that address root causes and prevent recurrence.
Ensure CAPAs consider manufacturing realities (equipment, process controls, operator training, procedural changes, facility conditions).
Track CAPA execution and conduct effectiveness checks to verify long‑term sustainability.
Create high‑quality investigation reports that meet GMP documentation standards and withstand audit/inspection scrutiny.
Ensure all investigations follow data integrity principles (ALCOA+).
Support internal audits and health authority inspections by presenting investigation rationale, documentation, and CAPA strategy as needed.
Review deviation and investigation trends to identify manufacturing process weaknesses and systemic issues.
Recommend improvements to procedures, equipment reliability, training programs, and production controls.
Partner with Manufacturing and Quality leadership to improve investigation cycle time and investigation quality.
Maintain a strong presence on the production floor to observe processes, interview operators, and confirm real‑time process understanding.
Provide coaching to operators and supervisors regarding deviation prevention and effective documentation practices.
Train cross‑functional teams on investigation methodologies, GMP expectations, root cause tools, and human factors analysis.
Maintain working knowledge of 21 CFR 210/211, 21 CFR 820, EU Annex 1, and related regulations
Ensure all work is performed in accordance with current regulatory requirements and internal SOPs
Support data integrity initiatives and provide input to compliance metrics
Supervise and develop a team of investigators
Provide regular feedback, performance evaluations, and coaching to team members.
Coordinate staffing to support manufacturing schedules and priority projects.