Quality Engineer

Overview

Simtra Bio Pharma Solutions is a world-class Contract Development Manufacturing Organization focused on sterile injectables, 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, all directly injected into patients worldwide.

There is a strong emphasis on quality and continuous improvement at Simtra, with adherence to high quality and regulatory standards. While our primary focus is cGMP manufacturing, we support 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.

Make it HAPPEN – We bring a growth mindset to every opportunity, develop new skillsets and exceed expectations for our customers. Make it TOGETHER – We work as one, respect every voice and leverage strengths across teams. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work and the impact we make on patient health.

The Quality Engineer is responsible for equipment and system validation, qualification and change control by partnering with cross-functional teams (Engineering, Technical Services, Manufacturing, etc.) to ensure timely execution and approval.

• Provides guidance and technical expertise in interpreting regulatory and Simtra requirements in validation strategy and processes.
• Quality signatory responsible for providing leadership, guidance, quality oversight and approval of commissioning, qualifications, and validations related to equipment utilized in the manufacturing of pharmaceutical drug products.
• Interfaces with Engineering, Technical Services, Manufacturing and Regulatory personnel as well as other technical disciplines to determine change control requirements. Assist and support the equipment and system validation activities.
• Conducts assessments of quality systems, identifies and closes gaps related to validation and corporate procedures.
• Guides peers, validation and engineering in the use of sound, statistically based quality engineering approaches in project and test planning and in the analysis and interpretation of test results. Studies and recommends improvements to existing products/processes.

• Experience working in a cGMP environment preferred.
• American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Trackwise, etc.).

• Must be able to wear appropriate personal protective equipment.
• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required.
• Position requires sitting or standing for long hours.

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance (Spouse and Child options)
• 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
• Voluntary Insurance Benefits (Vision, Accident, Critical Illness, Hospital Indemnity, Identity Theft Protection, Legal, and more)
• Onsite Campus Amenities (Workout Facility, Cafeteria, Credit Union)

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.

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 status or any other legally protected characteristic.