- Oversee everyday operation of the R&D Pilot Plant and Pharma Processing Labs. Supervise facility and schedule technicians to ensure productivity, quality, and safety. Schedule technicians and projects to ensure stakeholder needs are met. Ensure all appropriate safety and operating procedures are in place.
- Lead and support elastomer component product life cycle management activities. This could include supporting product line extensions, writing/reviewing/updating Design History File (DHF) documentation, addressing performance-related product complaints, learning and becoming a subject matter expert (SME), and performing risk analysis for changes that may affect product performance.
- Own and supervise selection and development of new or upgraded capabilities, as needed, to fulfill the mission of the labs and enhance a science-based approach for development and fine tuning of fill/finish and elastomer product design for standard processes and products.
- Responsible for the safety of workers and visitors in the R&D Pilot Plant and Pharma Processing Lab. The position will work closely with West's corporate safety officer to ensure compliance with all Corporate Safety Directives.
- Design and conduct engineering experiments and test protocols to make decisions affecting project direction (science-based approach).
- Write specifications and procedures for equipment working with Procurement and qualified suppliers.
- Accountable for the success and appearance of the R&D Pilot Plant and Pharma Processing Lab.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Exhibits regular, reliable, punctual, and predictable attendance.
- Education or Equivalent Experience: Bachelor's in Polymer Science, Mechanical Engineering, Chemical Engineering, Materials Science Engineering, or Biomedical Engineering. Master's preferred.
- Experience: 8-10 years of hands-on experience in process development and manufacturing of polymeric materials.
- Experience with design controls, product development, and test method development / validation.
- Knowledge of statistical evaluation of products and processes.
- Knowledge of manufacturing processes, workflows, basic electrical / automation equipment and industrial techniques.
- Experience and knowledge of processes used to produce elastomeric products (compression/injection molding, etc.)
- Knowledge of product performance requirements for pharmaceutical components, as well as processes used to develop, produce, and validate these products.
- Effective problem solving and interpersonal skills.
- Ability to plan work and coordinate lab technician scheduling, as needed.
- Working knowledge of Microsoft Office Suite, Statistical Analysis (Minitab), Azure DevOps.
- Six Sigma Green or Black Belt a plus
- Prior facilities and equipment management experience a plus.
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
- Able to comply with the company's safety policy at all times.
- Able to comply with the company's quality policy at all times.
- Must be able to travel 10-15% of the time business days per year)
- Ability to work in an R&D facility with industrial processes and equipment used to produce elastomeric products when needed. Use of gown, safety glasses, hairnet, face/beard cover, gloves, safety shoes and hearing protection as required.
- Must be able to perform job duties as required with limited physical demand within office, lab (25-35%), & manufacturing environments.
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Sr. Components Engineer - Exton, United States - West Pharmaceutical Services
Description
Hybrid position in Exton, PA. Candidates applying must be within a 50 mile commutable distance from the job location.Who We Are:
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary:
The Sr. Engineer, R&D, Components Labs & LCM will split duties between component life cycle management (LCM) engineering projects and the supervision of West Pharmaceutical Services' (WPS) R&D Pilot Plant / Pharma Processing Labs.
The R&D Pilot Plant is essential to WPS's research and development group for developing cutting edge elastomer products and process technologies utilizing processes such as compression molding. The Pharma Processing Lab operates and maintains equipment, such as a flexible filling, stoppering, and capping machine, in support of research, product characterization, and product development. The position is critical to ensuring the productivity, quality, and safety of all work, people, and equipment in the facility.
In addition, the position will lead projects and engineering efforts associated with the life cycle management of elastomer components. This individual will contribute exceptional analytical prowess, engineering proficiency, and organizational acumen to the team, thereby reinforcing West's standing as the industry leader in pharmaceutical primary packaging components.
Essential Duties and Responsibilities:
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.
