Engineering Compliance Associate

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.

This role:

The Engineering Compliance Associate is responsible for managing and maintaining workspaces including the "Desk.ly" reservation system. Other responsibilities will include supporting pest control and housekeeping, deviation investigation and reporting, SOP revision, and document routing and approval. This role will report to the Facility Maintenance Manager and is onsite 100% at the Bloomington, Indiana facility.

The responsibilities:

• Be the Subject Matter Expert (SME) of the "Desk.ly" reservation system and manage/track workspaces and support access for team members
• Collaborate with vendors and internal personnel to ensure adherence to pest control standards
• Own deviation investigations to support on-time batch release and facilitate Corrective & Preventive Action (CAPA) assignment and closure
• Amend and maintain governing procedures and support system updates/upgrades
• Support routing and approval of engineering documentation
• Support facility projects via purchase order submissions, contractor Chess training, maintenance planning with manufacturing ensuring all GMP requirements are followed during the task

Required qualifications:

• Associates degree or 3+ years related experience (preferred experience in the pharmaceutical or CDMO industry)
• Intermediate proficiency in Microsoft Office Suite) Word, Excel, Outlook) along with Dynamics and Veeva
• Consistent attention to detail essential for analyzing and reporting tasks (i.e., pest control tasks, SOP revision, deviation investigation, etc.)
• Strong communication and leadership skills
• Strong interpersonal, influencing, and negotiation skills
• Working knowledge of FDA regulations and application of current Good Manufacturing Practices (cGMPs)

Physical / safety requirements:

• Duties will require overtime work, including nights and weekends on occasion

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

• Short and Long-Term Disability 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

• 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 12/31/25

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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