Engineering Manager (Compliance)

Simtra US LLC; Bloomington (IN); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Paid Time Off

Job summary

Simtra US LLC is seeking an Engineering Compliance Manager to oversee regulatory compliance within the Engineering and Maintenance departments. This role involves managing a team and collaborating across functions to drive corrective actions and ensure audit readiness.

Job requirements include a BS degree in Engineering, 8+ years of pharmaceutical industry experience, and strong communication skills. Benefits include comprehensive health coverage, a 401(k) plan, and more.

Qualifications

• 8+ years of experience in the pharmaceutical/biotech industry preferred.
• Ability to manage multiple priorities in a fast-paced environment.
• Excellent oral and written communication skills.

Responsibilities

• Manage a team for compliance with regulatory documents.
• Drive corrective actions to closure without repeat occurrences.
• Ensure compliance and readiness for audits and inspections.

Skills

Communication skills

Organizational skills

Project management

Education

BS degree in Engineering or Life Sciences

Job description

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

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life‑changing medicines to patients worldwide.

Why join Team Simtra?

• Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
• Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams – so we can solve problems in new ways.
• Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
• 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.

The Role

The Engineering Compliance Manager manages a team of professionals responsible for compliance to regulatory and governing documents and practices within the Engineering and Maintenance departments. This position oversees closure of open gaps and drives improvement. This position reports to the Director of Engineering.

The 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. Facilitates governance for CAPA and finding closures. Tracks and reports progress, risks, and resource needs to leadership.
• 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 ensuring monthly pest control reports and trending analysis. Analyzes trends and implements corresponding facility improvements.
• Reporting team facilitates asset creation in ERP system, SOP revision, and engineering documentation review and approval.
• Ensures compliance to 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 for all direct reports. Assists in setting performance objectives and development plans.

The 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 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

• Day One 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
• Community and Volunteer Service Program
• Employee Ownership Plan
• Additional Benefits
  • Short and Long‑Term Disability Insurance
• Voluntary Insurance Benefits
  • Vision Coverage
  • Accident
  • Critical Illness
  • Hospital Indemnity Insurance
  • Identity Theft Protection
  • Legal and more
• Onsite Campus Amenities
  • Workout Facility
  • Cafeteria
  • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment 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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