Get new jobs for this search by email

Engineer | Senior Business Manager | @ EFOR

Job Title: Technical Writer GMP Compliance Remediation

Contract Type: Full-time / Contract

About EFOR

At EFOR, we are a global leader in Life Sciences consulting, with over 3,000 experts supporting our clients across pharmaceuticals, biotechnology, and medical devices. We specialize in delivering high-impact solutions across the entire product lifecycle from R&D through commercial manufacturing.

As part of our growing U.S. operations, we are currently seeking a Technical Writer to join a remediation project within a GMP-regulated pharmaceutical manufacturing environment. This high-visibility role supports documentation alignment efforts in response to compliance observations and regulatory expectations.

About the Role

You will collaborate closely with QA, Manufacturing, Engineering, and SMEs to revise and develop controlled documentation that meets current standards, supports audit readiness, and enables compliant operations.

Key Responsibilities

• Author, revise, and format SOPs, work instructions, protocols, and technical reports in line with cGMP and site standards
• Interface with cross-functional stakeholders (QA, Ops, Engineering, SMEs) to ensure documentation reflects accurate and usable procedures
• Ensure alignment with regulatory guidelines, including FDA 21 CFR Part 11 and data integrity principles
• Manage document updates and workflows within electronic document management systems (EDMS) such as Veeva, MasterControl, or Documentum
• Participate in remediation and documentation planning meetings; support deviation and CAPA write-ups where applicable
• Contribute to training material updates and procedural clarity for impacted user groups

Required Qualifications

• Bachelors degree in Life Sciences, Engineering, Technical Communication, or a related field
• 3+ years of experience in technical writing within pharmaceutical or biotechnology environments
• Strong understanding of GMP regulations and documentation best practices in a regulated setting
• Proficiency with EDMS platforms and controlled documentation workflows
• Excellent written and verbal communication skills

Preferred Qualifications

• Experience supporting regulatory remediation initiatives or warning letter responses
• Familiarity with deviation management systems and CAPA workflows
• Ability to manage multiple priorities in a fast-paced, compliance-focused environment

Why Join EFOR?

At EFOR, youll be part of a mission-driven consulting team working on impactful projects that shape the future of health. This role offers the opportunity to strengthen compliance and quality practices at a critical time while building your career within a growing international organization.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Consulting and Writing/Editing

• Industries

  Pharmaceutical Manufacturing, Business Consulting and Services, and Biotechnology Research

Referrals increase your chances of interviewing at EFOR by 2x

Inferred from the description for this job

401(k)

Vision insurance

Medical insurance

Disability insurance

Get notified about new Technical Writer jobs in Boston, MA.

Technical Author (multiple roles and seniority levels)

Technical Writer - Pharmaceutical Manufacturing

Hanscom Air Force Base, MA $105,000.00-$125,000.00 6 days ago

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.