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 is responsible for leading a team of process engineers in the development, optimization, reliability, and implementation of manufacturing processes to improve efficiency, quality, and safety. The ideal candidate will have a strong background in process engineering management and team leadership, with a proven track record of collaborating with cross-functional teams to identify opportunities for process improvements and implementing reliability and robust solutions.
What You'll Do
Supervise a team of process engineers to develop and implement reliability programs and robust strategies for aseptic filling and packaging lines
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 degree 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 (preferably in a CDMO)
Proven supervisory experience in leading engineers and/or other technical individuals with the ability to develop and motivate 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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