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Senior Process Engineer, HVP

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Date: May 27, 2021

Location: Kinston, North Carolina, US

Company: West Pharmaceutical Services

 

 

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:

 

The Senior Process Engineer, HVP will organize, coordinate, create and perform modifications, validations, and enhancements of processes, procedures, equipment and tooling to new and existing products and processes related to B2 Coating, Pharma Washing, Envision Processing and Sterilization.  The Senior Process Engineer, HVP will be accountable for implementing sustainable processes and will be responsible for measuring and reporting results to ensure qualified processes reach and sustain and improve production levels. This position requires the handling of formal and informal team member training. Management of personnel for process implementation and process improvements may be required.  This role also includes presenting a professional appearance in line with the following job responsibilities as well as presenting a professional attitude. 

 

 

Essential Duties and Responsibilities:

  • Support the implementation, development, transfer and improvements of processes and products within the facility related to pharma wash, sterilization, B2 coating, and clean room production. 
  • Interact with engineering, management, site and corporate team members, and/or vendors to develop engineering controls or required process improvements.
  • Initiate, support and execute HVP processing related CAPAs for Quality Initiatives or Complaints.
  • Ensure compliance to cGMP’s, Validation Master Plans, FDA, and other regulatory agency initiatives.
  • Plan, guide, coordinate or perform modifications, improvements, or new initiatives for new or existing products or processes within pharma wash, sterilization, and clean room technologies.
  • Plan, coordinate, or perform projects assigned to the approved schedules and budgetary commitments.
  • Support and recommend new and experimental product development activities related to pharma washing, sterilization, and clean room processing.
  • Support and Manage process or technology transfer projects between plants from a process standpoint as assigned.
  • Ensure all changes are appropriately documented through engineering studies, change controls or other methods of documenting change.
  • Support and lead Operations Excellence lean and continuous improvement initiatives.
  • Support projects and initiatives stemming from the Global Process Engineering Team.
  • Provide technical expertise/training to other plant personnel.
  • Research and analyze data to determine optimal processing conditions.
  • Support Engineering projects and Support Product Development as required.
  • Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency.
  • Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  • Maintains a clean, orderly, and safe workstation and environment at all times.
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
  • Exhibits regular, reliable, punctual, and predictable attendance.
  • Performs other duties as assigned based on business need.

 

 

 

Education and Experience:

  • Bachelor's in Engineering or technical degree
  • 5-8 years of relevant experience
  • 3+ years of experience within the pharmaceutical industry

Preferred Knowledge, Skills, and Abilities:

  • Sterilization and Pharma Wash experience.
  • Working knowledge of cGMP for Aseptic/Clean Room manufacturing.
  • Working knowledge of Validation life cycle and processes for regulated industries.
  • Ability to author/execute validation protocols, SOP’s/SOI’s.
  • Able to be aware of all relevant SOP’s as per Company policy as they are related to the position covered by this Job Description.
  • Self-motivated and solution-oriented personality.
  • Excellent written and verbal skills.
  • Good communication, project management, and interpersonal skills.
  • Good organizational skills.
  • Effective problem-solving skills.
  • Ability/courage to successfully communicate with any required parties.
  • Previous SAP experience a plus

 

Physical, Mental and Travel Requirements

  • Travel up to 10%
  • While performing the duties of this job on the production floor, the employee regularly stands, walks, talks, and hears.       
  • Noise level in the work environment while on the production floor is usually moderate to loud.  Hearing protection is required.
  • Must follow and comply with Plant’s Dress and Hygiene Code (SOI).
  • Must follow and comply with all Company and Plant policies, procedure (SOIs), rules and State and Federal laws

 

 

 

 

 

 

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.