Principal ×
Senior Consultant ×
CQV / Validation ×
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Featured
98% Match
Principal CQV Engineer — Aseptic Fill/Finish
Large Pharmaceutical Manufacturer · Devens, MA
📍 On-Site · Devens, MA
$160–175/hr
Posted 2 days ago
Lead CQV consultant needed for a $200M aseptic fill/finish expansion. Scope includes WFI, HVAC, clean steam, and filling line qualification. FDA PAI expected within 18 months. Must have hands-on aseptic experience and strong documentation background.
New
Urgent
94% Match
Senior QA Consultant — Warning Letter Remediation
Mid-Size Biotech · Cambridge, MA
📍 Hybrid · Cambridge, MA
$140–155/hr
Posted today
QA consultant needed immediately to support Warning Letter remediation program. Focus on CAPA system overhaul, deviation management, and FDA correspondence support. Immediate start preferred. Prior WL experience strongly preferred.
91% Match
CQV Lead — Cell & Gene Therapy Facility Buildout
Clinical Stage Biotech · Waltham, MA
📍 On-Site · Waltham, MA
$150–165/hr
Posted 4 days ago
Greenfield CGT manufacturing facility build. Looking for a CQV lead to own the full validation lifecycle from URS through PQ. Experience with single-use systems, cleanroom qualification, and IND-enabling studies a plus.
88% Match
Principal QA Consultant — CMO Oversight Program
Global Pharmaceutical Company · Remote / Travel
🌐 Remote + Travel Up To 50%
$145–160/hr
Posted 1 week ago
Remote-first QA consultant role supporting a CMO oversight program across 6 contract manufacturers in the US and EU. Responsibilities include audit execution, deviation review, and quality agreement management.
85% Match
Senior CQV Engineer — CSV / 21 CFR Part 11
CDMO · Devens, MA
📍 On-Site · Devens, MA
$125–140/hr
Posted 1 week ago
CSV-focused CQV engineer for a DCS and MES validation project at a commercial CDMO. Experience with GAMP 5, 21 CFR Part 11, and Veeva Vault required. KNEAT experience a strong plus.
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