Title: Sr. Staff MTO – Deviations, CAPA & Manufacturing Investigations
Location: Boston, MA (Seaport – 100% Onsite)
Employment Type: Contract (12+ Months)
Status: Accepting Candidates
About the role
Join a Manufacturing Technical Operations (MTO) team supporting Cell Therapy manufacturing operations. This role is responsible for owning and driving quality events, investigations, CAPAs, change controls, and operational compliance initiatives supporting GMP manufacturing activities.
The ideal candidate will have strong experience managing manufacturing investigations, leading root cause analysis activities, driving CAPA execution, and supporting GMP manufacturing environments.
Key Responsibilities
- Triage manufacturing issues in real-time on the manufacturing floor
- Lead investigations supporting:
- Manufacturing Operations
- Quality Control
- Material Operations
- Facilities Operations
- Own and manage:
- Deviations
- CAPAs
- Change Controls
- Risk Assessments
- Effectiveness Checks
- Lead root cause analysis activities using structured investigation methodologies
- Collaborate with SMEs to:
- Assess impact
- Determine containment actions
- Identify root cause
- Develop corrective actions
- Drive CAPA and Change Control records from initiation through closure
- Manage records within electronic Quality Management Systems (eQMS)
- Ensure compliance with GMP requirements and internal quality standards
- Promote operational compliance best practices and support continuous improvement initiatives
- Track and communicate quality metrics and operational compliance performance
- Support manufacturing operations and clinical production timelines
Qualifications
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, Biology, or related discipline
- 6+ years of pharmaceutical, biotech, biologics, or cell therapy manufacturing experience
- Strong experience owning:
- Deviations
- CAPAs
- Change Controls
- Risk Assessments
- Strong experience performing manufacturing investigations in GMP environments
- Experience conducting root cause analysis and implementing corrective actions
- Strong technical writing and documentation experience
- Experience working within electronic Quality Management Systems (eQMS)
- Strong communication and cross-functional leadership skills
- Ability to independently manage multiple investigations and compliance activities
Preferred Qualifications
- Cell & Gene Therapy (CGT) experience
- Biologics manufacturing experience
- Grade B cleanroom gowning experience
- Experience supporting manufacturing floor investigations in real-time
- Experience supporting regulatory inspections and audit readiness activities
- Experience using:
- Veeva
- TrackWise
- MasterControl
- Similar eQMS platforms
Compensation
- Estimated hourly range: $50–$56/hr (W-2)
- Final rate will be based on skills, experience, and interview results.
- Work Schedule:
- Monday–Friday
- 8:00 AM – 5:00 PM
