Engineering Manager (Compliance)

Responsibilities

• Manage a team of professionals responsible for compliance to regulatory and governing documents within Engineering and Maintenance
• Partner cross-functionally with Engineering, Maintenance, and Quality to drive corrective actions to closure
• Drive and maintain audit readiness and ensure compliance with procedures and facility drawings
• Manage deviation investigations, corrective actions, and on-time closure for batch release
• Collaborate with vendors to ensure adherence to pest control standards and analyze trends
• Facilitate asset creation in ERP system, SOP revision, and engineering documentation review
• Author, review, and approve protocols, reports, deviation investigations, change controls, and CAPAs
• Support regulatory inspections and client audits
• Interview, hire, coach, and develop staff

Requirements

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

Benefits

• Medical and Dental Coverage
• 401(k) with Company Match
• Paid Time Off and Paid Holidays
• Paid Parental Leave
• Education Assistance Program
• Employee Ownership Plan
• Onsite Campus Amenities including workout facility and cafeteria

About the Company

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