Engineering Manager (Compliance)

Simtra BioPharma SolutionsBloomington, Indiana

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Overview

Schedule

Full-time

Education

Engineering (PE)

Career level

Director

Remote

On-site

Benefits

Health Insurance

Dental Insurance

Vision Insurance

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?Because we:

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 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.

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 approval protocols, reports, deviation investigations, change controls, and CAPAs related to CQV scope

Support regulatory inspections and client audits

Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans

The Requirements (Education, Experience & Qualifications):

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

In return, you’ll be eligible for[1]:

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.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/

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FAQs About Engineering Manager (Compliance) Jobs at Simtra BioPharma Solutions

What is the work location for this position at Simtra BioPharma Solutions?

This job at Simtra BioPharma Solutions is located in Bloomington, Indiana, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Simtra BioPharma Solutions?

Employer has not shared pay details for this role.

What employment applies to this position at Simtra BioPharma Solutions?

Simtra BioPharma Solutions lists this role as a Full-time position.

What experience level is required for this role at Simtra BioPharma Solutions?

Simtra BioPharma Solutions is looking for a candidate with "Director" experience level.

What education level is required for this job?

The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.

What benefits are offered by Simtra BioPharma Solutions for this role?

Simtra BioPharma Solutions offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Disability Insurance, Life Insurance, Family/Dependent Health, Paid Holidays, Paid Vacation, Parental and Family Leave, Paid Community Service Time, 401k Matching/Retirement Savings, Tuition/Education Assistance, and Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.

What is the process to apply for this position at Simtra BioPharma Solutions?

You can apply for this role at Simtra BioPharma Solutions either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.