cGMP Compliance Engineer - Biotech Ops

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 129,000; Full time

Benefits offered by this job

Annual bonuses

401(k) company match

Health and wellness programs

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Compliance Specialist in Troy, NY. The role focuses on cGMP and procedural compliance for Engineering & Automation, supporting documentation, change controls and CAPAs, and interacting with Quality/Regulatory teams.

On-site, Monday–Friday, with opportunities to present to leadership and regulators. Qualifications include a Bachelor’s degree in life sciences or engineering and 2+ years in a related role.

Qualifications

• Requires a B.S. in life sciences, engineering or related field, or equivalent.
• Knowledge of cGMP biotech/pharma operations and regulatory guidance.
• Ability to manage multiple documents and audit readiness.

Responsibilities

• Maintain up-to-date knowledge of cGMPs and industry guidance and evaluate practices.
• Maintain and review documentation, change controls, investigations and CAPAs.
• Serve as liaison between Engineering & Automation and Quality/Regulatory groups.
• Identify improvement opportunities and support related initiatives.
• Coordinate audits, respond to findings, and track trends across QA and regulatory audits.
• Present to senior management and regulatory agencies; communicate clearly in writing.

Skills

cGMP knowledge

Regulatory liaison

Documentation management

Education

Bachelor's degree in life sciences or engineering

Job description

Regeneron Pharmaceuticals, Inc. seeks a Compliance Specialist in Troy, NY. The role focuses on cGMP and procedural compliance for Engineering & Automation, supporting documentation, change controls and CAPAs, and interacting with Quality/Regulatory teams.

On-site, Monday–Friday, with opportunities to present to leadership and regulators. Qualifications include a Bachelor’s degree in life sciences or engineering and 2+ years in a related role.