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.
• 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
• 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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What We Do
As a premier, independently owned CDMO with over 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class cGMP sterile fill/finish, technical expertise, quality service, and a uniquely collaborative approach. Pharmaceutical and biotech companies partner with us when they face formulation challenges, clinical supply hurdles, surges in demand due to market fluctuations, or risk mitigation concerns. Our teams are driven to offer our clients tailored and versatile solutions to help them bring their products to market so they can get to the patients who need them.
(Simtra is a tradename of Baxter Oncology GmbH and Baxter Pharmaceutical LLC)