Engineering Compliance Leader: CAPA, CQV & Audit Readiness

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

401(k) Retirement Savings Plan with Company Match

Paid Time Off

Education Assistance Program

Job summary

Simtra BioPharma Solutions is seeking an Engineering Compliance Manager in Bloomington, Indiana. This role involves overseeing regulatory compliance within Engineering and Maintenance, ensuring audit readiness, and managing a team responsible for deviation investigation.

The ideal candidate will have effective communication skills, strong organizational abilities, and a BS degree in a related field, along with 8+ years of experience in the pharmaceutical or biotech industry.

Benefits include medical coverage, 401(k) retirement plan, and an education assistance program.

Qualifications

• 8+ years experience in the pharmaceutical/biotech industry preferred.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Partner cross-functionally to drive corrective actions to closure.
• Maintain audit readiness and ensure compliance with procedures.
• Manage a team for deviation investigation and batch release closure.
• Collaborate with vendors for adherence to pest control standards.
• Review and approve protocols, reports, and CAPAs related to CQV scope.
• Support regulatory inspections and client audits.

Skills

Communication skills

Organizational skills

Project tracking

Cross-functional team influence

Education

BS degree in Engineering, Life Sciences or related technical field

Job description

Simtra BioPharma Solutions is seeking an Engineering Compliance Manager in Bloomington, Indiana. This role involves overseeing regulatory compliance within Engineering and Maintenance, ensuring audit readiness, and managing a team responsible for deviation investigation.

The ideal candidate will have effective communication skills, strong organizational abilities, and a BS degree in a related field, along with 8+ years of experience in the pharmaceutical or biotech industry.

Benefits include medical coverage, 401(k) retirement plan, and an education assistance program.