Location: Kinston,NC, USA
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 HVP Process Engineer 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.
Essential Duties and Responsibilities:
* Support the implementation, development, transfer and improvements of processes and products within the facility related to pharma wash, sterilization and clean room production. Ensure these new processes/products are commercially viable at hand off to operations.
* Initiate, support and execute HVP processing related CAPAs, 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.
* Ensure Engineering records and documentations related to equipment, products, and product development are accurately recorded per Validation Master plans and are properly maintained.
* Review/Revise procedures to ensure they reflect the most current and effective means of describing processes.
* Support and Champion West Values to ensure the success of the Kinston site and West as a Global Market Force.
* Safeguard confidential information.
* Maintain and promote effective team member relations, ensuring that we have team member agreement of new layouts or procedures.
* Conforms with and abides by all regulations, policies, work procedures, instructions and safety policies.
* Other duties as assigned based on business needs.
Basic Qualifications:
* Education: Bachelors in Engineering preferred, equivalent engineering experience with science discipline acceptable.
* Excellent written and verbal skills.
* Excellent interpersonal skills; good team player and individual contributor.
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.
* Working knowledge of Minitab or SPC software for tracking and trending KPI's/performance.
Travel Requirements:
* Travel up to 10%.
Physical & Mental Requirements:
* Office and manufacturing environment.
* Ability to lift files, open filing cabinets and bend or stand as necessary.
* Must follow and comply with Plant's Dress and Hygiene Code (SOI)
* Regularly uses hands and fingers to operate objects, tools or controls. Frequently required to stand, talk and hear for long periods of time.
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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 ...@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.