Engineering Manager (Compliance)

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

About Simtra BioPharma Solutions

Simtra BioPharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.

The Role

Engineering Compliance Manager – manages a team responsible for regulatory compliance within the Engineering and Maintenance departments, overseeing closure of gaps, driving improvement, and reporting to the Director of Engineering.

Responsibilities

• The Compliance Manager partners cross‑functionally across Engineering, Maintenance, and Quality to drive open E&M owned corrective actions to closure without repeat occurrences, facilitating governance for CAPA and finding closures.
• Drives and maintains audit readiness; ensures compliance with procedures and maintains facility/site drawings.
• Manages a team responsible for deviation investigation, corrective actions, and on‑time closure for batch release.
• Collaborates with vendors and internal personnel to ensure adherence to pest control standards, responsible for monthly reports and trending analysis, and implements facility improvements.
• Facilitates asset creation in the ERP system, SOP revision, and engineering documentation review and approval.
• Ensures compliance with procedures and reviews practices, including logbook reviews and vendor checks.
• Author, review, and approve protocols, reports, deviation investigations, change controls, and CAPAs related to CQV scope.
• Supports regulatory inspections and client audits.
• Interviews, hires, coaches, and develops staff; conducts annual performance reviews and assists in setting performance objectives and development plans.

Requirements

• BS degree in Engineering, Life Sciences, or related technical field.
• 8+ years experience in the pharmaceutical/biotech industry preferred.
• Excellent oral and written communication skills with the ability to influence cross‑functional teams.
• Strong organizational, planning, and project tracking skills.
• Ability to manage multiple priorities in a fast‑paced environment.

Benefits

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program