Engineering Manager; Compliance

About Simtra Bio Pharma Solutions

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

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.

• 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.

• 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.

• 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