Senior Manufacturing Engineer

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

About the Role

Reporting to the Sr Project Mgr - Product Development at the Hobart Site, the Senior Manufacturing Engineer will collaborate with Product Research and Development (R&D) at the Webster Groves Site to assist in the development, scale-up, and transfer of new products to the Hobart site. As products from purchased ANDAs, other pharmaceutical companies, and internal R&D are sanctioned, the candidate will execute projects as the Technical Lead. This role serves as the Subject Matter Expert (SME) for development, scale-up, tech transfer, validation, and commercialization of Oral Solid (Tablets and Capsules) and Oral Liquid Dosage Forms. The Senior Manufacturing Engineer will also support legacy product manufacturing, resolve process difficulties, reduce waste, improve productivity and safety, and provide technical support to site operations, maintenance, and manufacturing personnel.

Responsibilities

• Evaluate the feasibility of new products for development and approved ANDAs from other pharmaceutical companies for tech transfer and commercialization.
• Technically lead products from development through commercialization, including validation support.
• Evaluate second-source API vendors and excipient suppliers.
• Resolve plant CAPAs with subject matter expertise.
• Evaluate customer complaints related to physico-chemical characteristics of dosage forms.
• Support equipment (e.g., Fluid Bed Dryer) upgrades.
• Manage extension of product expiry dating and component changes (bottles/caps), including product monitoring.
• Facilitate product transfers between tablet presses and new launches.
• Scale-up and scale-down current commercial product batch sizes.
• Use problem-solving techniques to resolve manufacturing issues, reduce cost and waste, and improve quality in existing processes.
• Develop, write, and execute development protocols for existing products and new product transfers.
• Support maintenance and production activities, including equipment design/setup, equipment/parts changes, and process modifications.
• Provide technical leadership for productivity improvement and cost-reduction projects.
• Review all process changes to enhance operation, reliability, efficiency, and safety.
• Serve as the primary resource for resolving technical process issues.
• Support productivity improvements through process upgrades and new process start-ups, including equipment and process development.
• Apply knowledge of materials sciences for solid and liquid dosage formulation characterization and scale-up projects.
• Manage development activities to ensure projects meet schedule requirements.
• Develop and write product manufacturing instructions, characterization protocols, and reports.
• Complete statistical analysis of data using DOE, statistical techniques, total quality management, and Six Sigma principles.
• Work with the Sr Project Mgr - Product Development to develop project scope and cost details for budget preparation.
• Participate regularly in daily Product and Process Technology meetings.
• Assist project engineering with installation and startup of process and product upgrade projects.
• Manage special projects or tasks as assigned.

Requirements

• MS or Ph.D. with a related technical background preferred.
• Demonstrated ability to troubleshoot pharmaceutical operating equipment and support equipment.
• Pharmaceutical formulation experience and/or scale-up experience with solid and liquid dosage formulations.
• Minimum of 3–5 years of relevant experience.
• Strong written and verbal communication skills, including technical communication.
• Hands-on experience in the manufacture of pharmaceutical products, with an understanding of solid and liquid formulations.

Skills

• Strong technical and mathematical aptitude.
• Proficiency in MS Office products, statistical analysis (Minitab), and database usage.
• Knowledge of DOE, statistical techniques for data analysis, total quality management, and Six Sigma in manufacturing.
• Ability to direct and motivate personnel across departments.

Working Conditions

• 55% of time spent in the office, 45% on the production floor.
• Potential opportunities for travel.

Pay

The expected base pay range for this position is $78,000–$121,000. Base pay offered may vary depending on job-related knowledge, skills, and experience. This position is eligible for a bonus in accordance with the terms of the applicable program, awarded at the Company’s discretion.