Senior Process Validation Engineer - GMP/CMO Lead (Remote)

Stoke Therapeutics; Bedford (MA); Hybrid; USD 140,000 - 161,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

Medical, dental, vision insurance

401(k) with match

Tuition assistance

ESP P

Job summary

Stoke Therapeutics, headquartered in Bedford, MA, seeks a Senior Engineer/Manager, Process Validation to lead validation activities for DS/DP, labeling, packaging, and shipping across CMOs. The role reports to the Director of Manufacturing Validation and requires collaboration with Manufacturing, QA, Regulatory, and Supply Chain.

Ideal candidates have 8+ years (BS) or 6+ years (MS) in pharma/biotech process validation, with expertise in cGMP, ICH Q8-Q11, and FDA guidelines, plus experience with

Qualifications

• Bachelor’s degree in engineering, Life Sciences or related field.
• 8+ years of experience or a Master’s with 6+ years.

Responsibilities

• Lead and execute process validation projects for drug substance and drug product.
• Develop PV master plans, risk assessments and validation strategies.
• Coordinate with CMOs and internal teams to plan and review validation activities.
• Define acceptance criteria, sampling plans and load configurations.

Skills

Process validation

GMP

ICH Q8-Q11

FDA Process Validation

CMO coordination

DOE / SPC

Education

Bachelor's degree in engineering or Life Sciences

Master’s degree

Tools

JMP

Job description

Stoke Therapeutics, headquartered in Bedford, MA, seeks a Senior Engineer/Manager, Process Validation to lead validation activities for DS/DP, labeling, packaging, and shipping across CMOs. The role reports to the Director of Manufacturing Validation and requires collaboration with Manufacturing, QA, Regulatory, and Supply Chain.

Ideal candidates have 8+ years (BS) or 6+ years (MS) in pharma/biotech process validation, with expertise in cGMP, ICH Q8-Q11, and FDA guidelines, plus experience with