BostonFull TimeEngineering
Remotely
documentationregulatory compliancereport writingveeva vaultcgmpdocumentumprocess characterization21 cfr part 211
Job Description
📋 Description
- Draft conclusion-driven process development reports from objectives and SME input, translating
- Structure reports per internal templates and late-stage CMC documentation standards with rationale
- Transform raw experimental data into tables, figures, and summaries for regulatory readiness and
- Produce complete first drafts with minimal SME revision to accelerate documentation timelines.
- Maintain traceable, inspection-ready source documentation to support submissions and lifecycle
- Collaborate across process development functions to align reporting approaches across programs.
🎯 Requirements
- B.S. or higher in chemistry, engineering, or related field; 4+ years (or M.S. with 2+ years; PhD
- Strong written and verbal English; familiarity with cGMP, 21 CFR Part 211, and ICH guidelines
- Proficiency in MS Word, Excel; experience with an EDMS (Veeva Vault, Documentum, or similar).
- Experience in process characterization, purification chromatography, scaling design, and late-stage
- Attention to detail, data analysis, and problem-solving; ability to work independently and meet
- Ability to work in the United States indefinitely without sponsorship.
🎁 Benefits
- Comprehensive medical, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Bonus opportunities and merit-based increases
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