Simtra BioPharma Solutions
Engineering Manager (Compliance)
Bloomington, Indiana, United States
Sponsorship not specifiedDetected 12 days ago
ERPPerformance ManagementGMPCommunication
About the role
- This position reports to the Director of Engineering.
- Facilitates governance for CAPA and finding closures.
- Tracks and reports progress, risks, and resource needs to leadership.
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.
- Drives and maintain Audit Readiness; ensure compliance with procedures and maintain 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 ensuring monthly pest control reports and trending analysis. Analyze trends and implement corresponding facility improvements.
- Support regulatory inspections and client audits
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- BS degree in Engineering, Life Sciences, or related technical field
- Excellent oral and written communication skills with the ability to influence cross-functional teams
Nice to have
- 8+ years experience in pharmaceutical/biotech industry preferred
Skills
- Strong organizational, planning, and project tracking skills
Compensation
- Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans
Benefits
- Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
Company info
- With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Equal opportunity
- Simtra is proud to be an equal opportunity employer.
- Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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