Manager, Process Engineering

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 Supervisor is a key member of the Finishing Leadership Team and reports directly to the Finishing Operations Manager. This role is responsible for supporting day-to-day operations in the Finishing production area, ensuring safe and efficient execution of the production schedule in compliance with current Good Manufacturing Practices (cGMP) and safety standards. The Supervisor leads a team of direct reports and cross-functional partners to drive performance, optimize equipment efficiency, and identify opportunities for continuous improvement using LEAN Manufacturing principles. This role requires a hands-on leader who can effectively support and enhance production floor activities, while fostering a culture of operational excellence. Strong communication skills are essential, as the Supervisor regularly interacts with production team members, management at various levels, and support departments. The ideal candidate will demonstrate a commitment to safety, quality, and productivity, and will uphold the highest standards of SISPQ (Safety, Identity, Strength, Purity, and Quality) in all aspects of production.   Its responsibilities: * Understand and follow current Good Manufacturing Practices * Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations. * Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans. * Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities – to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence. * Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals. * Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations. * Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments. * Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes. * Resolve technical, material and cGMP problems that may impact project deadlines. * Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable. * Represent the company during audits and inspections. * Author Non-conformance investigation reports (NCRs).   Desirable qualifications: * High School diploma or GED required * Minimum 2 years of manufacturing experience required * Minimum 1 year leadership experience required * In-depth process knowledge of related manufacturing equipment and processes preferred * Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred * Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  Veeva, Trackwise, SCADA (or similar) system, etc.)  Physical / safety requirements: *  Required to stand for over 4 hours per day, including constant standing for 2 hours at a time *  Duties may require overtime work, including nights and weekends *  Use of hands and fingers to manipulate equipment is required 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 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 Privacy Policy: Privacy Policy — Simtra BioPharma Solutions [https://simtra.com/privacy-policy/]