For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

We are seeking a Process Engineering Manager to lead our process engineering team. The ideal candidate will have a strong background in process engineering management and team leadership, with a proven track record of implementing process optimizations and driving reliability and robust processes.

What you'll do:

• Lead a team of process engineers to develop and implement reliability programs and strategies for filling and packaging lines and mentor team members through training and coaching to build a high-performing and engaged team
• Establish and maintain key performance indicators to monitor equipment reliability, availability, and improvement effectiveness
• Collaborate with cross-functional teams to identify and prioritize improvement opportunities and drive implementation of solutions
• Develop and manage budgets to support continuous improvement initiatives
• Implement and maintain preventive maintenance programs to minimize equipment downtime and maximize production efficiency
• Champion process improvement opportunities to reduce costs, streamline workflows, and enhance overall operational efficiency
• Ensure compliance with regulatory requirements and quality standards in all engineering activities. Track and monitor successful and timely implementation and effectiveness of corrective actions and change controls.
• Provide technical expertise and support for troubleshooting and resolving complex equipment, including investigation and authoring of nonconformance reports by team members.

What you'll bring:

• BS in Engineering or related field (including technology degree)
• 8 years of experience in pharmaceutical manufacturing with a focus on reliability engineering, maintenance, or process engineering
• Proven experience in leading and managing a team
• In-depth knowledge of reliability engineering principles, methodologies, and best practices
• Strong project management skills with experience in leading and executing reliability improvement projects
• Excellent analytical and problem-solving skills, with the ability to apply data-driven approaches to drive continuous improvement
• Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams and communicate complex technical concepts to non-technical stakeholders

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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.

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Reasonable Accommodations

Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy