Technical writer

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

We are seeking a contract Technical Writer / Deviation Specialist to support the Manufacturing Science and Technology (MSAT) team within our Cell Therapy manufacturing organization during a 6-month site capacity ramp-up. This role is critical to maintaining quality and compliance momentum as the site scales production, focusing primarily on deviation management and technical documentation, with additional support for equipment impact assessments and cross-functional troubleshooting. The ideal candidate is detail-oriented, comfortable working in a GMP manufacturing environment, and able to translate complex manufacturing data into clear, defensible quality documentation.

Key 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 (15?25%)
• Secondary (10%)
• 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
• Perform gowning activities and enter manufacturing plant areas as needed (routine exposure to strong magnetic fields is common in these areas)

Must Have Qualifications

• Required Bachelor's degree in life sciences, engineering, or related technical field (or equivalent experience)
• 1 years 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.

Preferred Qualifications

• Experience specifically within cell therapy, gene therapy, or other advanced therapy manufacturing
• Experience with equipment impact assessments and out-of-tolerance (OOT) evaluations
• Familiarity with MSAT function and its interface with Quality and Manufacturing
• Prior contract/consulting experience supporting capacity ramp-ups or tech transfers

Technical Skills

• Deviation/CAPA lifecycle management within a QMS platform
• Data analysis and summarization from manufacturing/batch records
• Technical writing for regulated GMP documentation
• Familiarity with equipment qualification/calibration concepts (for OOT and impact assessments)

Non Technical Skills

• Strong written communication and documentation clarity
• Cross-functional collaboration and stakeholder management
• Ability to prioritize and manage multiple concurrent deviations/investigations
• Comfort operating with ambiguity in a fast-paced, ramp-up environment
• Attention to detail and compliance mindset

Additional Standout Experience

• Prior experience in cell therapy MSAT or manufacturing technical support specifically
• Track record of driving deviation aging/backlog reduction
• Experience supporting a facility during scale-up, tech transfer, or new product introduction
• Familiarity with strong magnetic field safety protocols (e.g., relevant to certain cell therapy processing equipment)

100% onsite (with some flexibiity to work remote)

Work Schedule:

Mon-Fri (normal business hours)

This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb.

The starting hourly compensation for this assignment is the following range ($38- $41.96/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.

Benefits

ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.

Equal Opportunity Employer

ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.

California Applicant Notice

ASK Consulting is committed to complying with the California Privacy Rights Act (CPRA), effective January 1, 2023, as well as all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by [e-mail].

Fair Chance Employment Notice

If you are selected for a position at, ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local Fair Chance ordinances and laws such as the Los Angeles County Fair Chance Ordinance (FCO) and the California Fair Chance Act (FCA) we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer.

To learn more about how ASK Consulting collects and uses personal information during the recruiting process, please review our Privacy Notice and CCPA Addendum. As part of our recruitment efforts, we may ask you to disclose various categories of personal information, including identifiers, professional details, commercial information, educational background, and other related data. ASK Consulting will use this information solely to facilitate the recruitment process.

This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered at will, regardless of the expected assignment duration.