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Title:  Sr. Engineer - Pharma Processing

Requisition ID:  34983
Date:  Oct 7, 2021
Location: 

Exton, Pennsylvania, US

Department:  R&D
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

West Pharmaceutical Services, Inc. is a leading global manufacturer in the design and production of technologically advanced, high-quality, integrated containment and delivery systems for injectable medicines. We are a trusted partner to the world’s top pharmaceutical and biotechnology companies — working by their side to improve patient health. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia.

 

This role resides within the Pharmaceutical Processing Group (PPG) of the Research & Development (R&D) business unit. PPG is responsible for providing subject matter expertise concerning pharmaceutical processing and fill/finish operations to the broader West organization to facilitate new product development and fill/finish customer enablement. In addition to subject matter expertise, PPG operates and maintains equipment, such as a flexible filling, stoppering, and capping machine, in support of research, product characterization, and product development.

 

In this role, you will be responsible for supporting the PPG deliverables by executing the essential duties described below. The ideal candidate will have an in-depth understanding of global regulatory requirements for, and direct experience in, the cGMP manufacturing of parenteral products.

 

Essential Duties and Responsibilities:

  • Provide expertise, best practices, recommendations, and fill/finish VOC to the broader West organization to ensure that West products are appropriately designed and manufactured to enable subsequent fill/finish processing (for example, filling, lyophilization, closing, and sealing).
  • Provide expertise, best practices, and recommendations to customers and CMOs for facility design and fill/finish process lifecycle implementation (for example, from feasibility, detailed design, startup, commissioning, qualification, commercial manufacturing, and continuous improvement).
  • Lead or assist with the design and procurement of new equipment, format parts, and equipment modifications.
  • Participate in project core teams for development of new products.
  • Partner with commercial account managers to share strategies and techniques which are unique to West products with customers, CMOs, and OEMs.
  • Operate, troubleshoot, and maintain any assigned equipment, including the automatic flexible filler, semi-automatic filling and capping machines, and/or other equipment as assigned and in accordance with established safety and quality requirements.
  • Perform equipment troubleshooting.
  • Disassemble and reassemble equipment to facilitate product change-over.
  • Recognize and report immediately any incidents or potential issues (safety, operational, etc.) to management.
  • Lead or assist with the development of test plans. Collaborate with West colleagues to determine test execution and operating requirements. Provide feedback as necessary to support the development of appropriate test plans.
  • Perform test execution and document the execution of the test plan within the approved test protocol, in accordance with Good Documentation Practices.
  • Lead or assist with root cause investigations, CAPA development and execution, the development of standard operating procedures, FMEAs and other risk/impact assessments.
  • Collaborate with R&D colleagues in support of interdepartmental initiatives.
  • Other duties as assigned.

 

Basic Qualifications: 

  • Bachelor’s Degree or equivalent in engineering, science, technology, or other relevant technical field.
  • Minimum 5 years of direct experience in the design, startup, commissioning, qualification, and/or cGMP manufacturing of biopharmaceutical or parenteral products.
  • Familiarity with change management and the validation lifecycle of cGMP equipment and processes.
  • Strong analytical skills, an understanding of statistics, and familiarity with quality by design and the principles of engineering.
  • Self-motivated, have strong attention to detail, and be able to work independently as well as in team settings.
  • Comfortable with ambiguity and developing engineering solutions to complex problems.
  • Proficiency with verbal and written communication in the English language and with colleagues across different levels within the organization.
  • Ability to navigate documentation systems, and to identify and interpret documentation required to perform the assigned duties, including company policies, SOPs, test protocols, design documents, drawings (dimensional, mechanical, electrical, piping/instrumentation, and network), and supplier turnover documentation.
  • Ability to identify safety and operational incidents or potential risks and initiate investigative and/or remedial actions.
  • Must be willing to work overtime and/or outside of normal business hours, including nights, weekends, and holidays, in order to fulfill project deliverables or to interface with customers and colleagues located in other countries or time zones.
  • Ability to plan work and prioritize multiple tasks.
     

Preferred Knowledge, Skills and Abilities:

  • Experience in automated fill/finish of biopharmaceutical cGMP products, especially container filling, stoppering, capping, and other processes common to fill/finish manufacturing facilities.
  • Experience with creating user requirements and technical specifications for automated manufacturing equipment.
  • Working knowledge of aseptic processing techniques.
  • Experience with regulatory audits and inspections.
  • Proficiency with SolidWorks modeling software.
  • Direct experience managing projects.

 

Travel Requirements:

  • Must be able to travel domestically and internationally up to 10% of the time.

 

Physical & Mental Requirements:

  • Sitting, standing, bending over, crouching, working within difficult-to-reach areas of the equipment, unassisted lifting of equipment up to 50 lbs, and repetitive motions while wearing appropriate gowning and PPE.
  • Rational thinking and making safe and correct improvised decisions during operation or troubleshooting of tools, machinery, and control systems, including the correct application of lockout/tagout as well as the correct application of tools, PPE, and techniques.
  • Maintaining attention to detail while completing multiple repetitive tasks.

 

Competencies/Authorities

  • Non-US only where required for certain levels

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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