MSAT Technical Writer & Deviation Specialist

Bristol Myers Squibb; Harvard (MA); Hybrid; USD 34,000 - 58,000; Full time

Benefits offered by this job

Health insurance

Dental

Vision

Disability insurance

Commuter benefits

401(k)

Referral bonus program

Job summary

ASK Consulting seeks a contract Technical Writer / Deviation Specialist to support Bristol Myers Squibb's MSAT Cell Therapy site during a 6-month ramp-up. The role focuses on deviations, technical documentation, and cross-functional troubleshooting in a GMP environment.

Responsibilities include impact assessments, equipment-related work, and collaboration with Scheduling, Global MSAT, Quality, and Facilities & Engineering. Onsite with some remote flexibility; Mon-Fri.

Qualifications

• Bachelor's degree in life sciences, engineering, or related technical field.
• 1 year of experience in a GMP-regulated biotech/pharma manufacturing environment.
• Direct experience authoring and/or managing deviations within a quality management system (e.g., TrackWise, Veeva QMS).
• Demonstrated ability to write clear, technically sound investigation and impact assessment documentation.
• Ability to gown and work in a cleanroom/manufacturing environment.

Responsibilities

• Facilitate deviations from opening through documentation, impact assessment, prevention planning, and closure within site quality systems.
• Analyze and summarize manufacturing data to support impact assessments and investigations.
• Support equipment impact assessments, out-of-tolerance (OOT) reports, and routine equipment assessments.
• Provide ad-hoc technical support for troubleshooting routine manufacturing issues.
• Interface with cross-functional teams including Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering.

Skills

Deviation management

Technical writing

Data analysis

Cross-functional

Gowning in cleanroom

Education

Bachelor's degree in life sciences, engineering, or related technical field

Tools

TrackWise

Veeva QMS

Job description

ASK Consulting seeks a contract Technical Writer / Deviation Specialist to support Bristol Myers Squibb's MSAT Cell Therapy site during a 6-month ramp-up. The role focuses on deviations, technical documentation, and cross-functional troubleshooting in a GMP environment.

Responsibilities include impact assessments, equipment-related work, and collaboration with Scheduling, Global MSAT, Quality, and Facilities & Engineering. Onsite with some remote flexibility; Mon-Fri.