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About the Role

Par Health is seeking a Senior Manufacturing Engineer to assist in the development, scale-up, and transfer of new products. This role involves technical leadership from development through commercialization, troubleshooting manufacturing issues, and supporting productivity improvements.

Responsibilities

• Evaluate the feasibility of new products for development and approved ANDA’s 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 CAPA’s with Subject Matter Expertise.
• Evaluate customer complaints related to physico-chemical characteristics of Dosage Form.
• Manage Equipment (Fluid Bed Dryer) upgrades.
• Manage Extension of Product expiry dating.
• Manage Component changes (bottles/caps) and product monitoring.
• Manage Product transfers between Tablet presses.
• Manage New launches.
• Perform Scale-up and scale-down of current commercial product batch sizes.
• Use problem-solving techniques to resolve manufacturing issues, reduce cost, waste, and improve quality with existing processes.
• Develop/write/execute development protocols for existing products and new product transfers.
• Support maintenance and production activities, including equipment design/set-up, equipment/parts changes, and process modifications.
• Provide technical leadership in support of productivity improvement and cost reduction projects.
• Review all process changes to improve products for operation, reliability, efficiency, and safety.
• Act as the primary resource for resolving technical process issues.
• Support productivity improvements through process upgrades.
• Support new process start-ups, including equipment and process development.
• Apply knowledge and practical application of materials sciences for solid and liquid dosage formulation characterization and scale-up projects.
• Manage development activities to ensure projects meet development schedule requirements.
• Develop/write product manufacturing instructions.
• Develop/write product characterization protocols and reports.
• Complete statistical analysis of data.
• Work with Sr Project Mgr - Product Development to develop project scope and cost details for project budget preparation.
• Participate 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/Ph.D preferably with related technical background.
• 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 3 - 5 years of experience.
• Strong written and verbal communication skills, including technical communication skills.
• Understanding of solid and liquid pharmaceutical formulations.
• Hands-on experience in the manufacture of pharmaceutical products.
• Strong technical and mathematical aptitude.
• Strong computer literacy—MS office products, statistical analysis (Minitab), and database usage.
• Requires interaction with various internal and external department heads, supervisors, and operators to coordinate Product and Process Transfers.

Skills

• Problem-solving techniques
• Fluid-bed related activities
• Fluid Bed Granulation, Drying and Coating
• Tableting and Encapsulation
• Materials sciences for solid and liquid dosage formulation characterization
• DOE
• Statistical techniques for data analysis
• Total quality management
• Six Sigma in manufacturing
• Strong communication skills
• Ability to direct and motivate personnel
• Technical communication skills
• MS office products
• Statistical analysis (Minitab)
• Database usage

Location

• Hobart Site
• Webster Groves Site

Work Type

• Office
• Production floor

Experience Level

• Senior
• 3-5 years

Education Level

• MS/Ph.D

About the Company

• 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.

Equal Opportunity

• We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law.
• This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.