Science and Compliance Specialist

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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 Science and Compliance Specialist serves as an operations SME providing technical guidance on aseptic practices and equipment drafting and revising SOPs and controlled documents and supporting production teams through troubleshooting process optimization and documentation accuracy. The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment applying structured problem-solving methods to identify root causes maintain accurate cGMP compliant records and drive effective CAPA implementation. It requires managing multiple investigations simultaneously and supporting audits by clearly communicating findings.

The responsibilities:

• Lead and execute investigations for deviations including defining scope applying structured problemsolving methods and documenting results in compliance with cGMP standards.
• Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
• Investigate the root cause(s) of the issue and document the investigation results
• Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
• Collaborate with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectiveness
• Manage multiple investigations simultaneously ensuring timely progression and compliance with deadlines
• Represent operations during audits and inspections by clearly explaining investigation scope rationale findings and supporting data
• Review and analyze operational data to identify trends recurring issues and opportunities to reduce downtime increase yield and improve operator efficiency
• Partner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety quality efficiency and overall process performance
• Serve as an operations subject matter expert (SME) providing technical guidance on process performance aseptic practices and equipment operation
• Draft revise and approve Standard Operating Procedures (SOPs) and other controlled documents to ensure accuracy clarity and compliance with regulatory expectations

Required qualifications:

• BS degree preferably in a science or technical area or equivalent aseptic pharmaceutical manufacturing experience
• 2 years technical writing experience preferably in pharmaceutical industry
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Knowledge of applicable CAPA procedures specifications regulations and standards
• Microsoft Office Suite (Word Excel PowerPoint and Outlook) intermediate proficiency
• Goal-setting prioritize organization attention to detail and time management skills
• Critical & creative thinking and problem-solving skills
• Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
• Strong oral and written communication skills
• Ability to demonstrate strong leadership skills
• Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
• Ability to utilize enterprise software systems (Veeva)

Physical / safety requirements:

• Duties will require overtime work including nights and weekends on occasion
• Ability to gown in C/D gowning area

In return youll be eligible for1:

• 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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