Validation Engineering Technician 68973
Validation Engineering Technician 68973
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1 Vacancy
Job Description
At West were 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 lifesaving and lifeenhancing injectable medicines to millions of patients daily Wests indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future
Theres 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.
Please live within 50 miles of our Williamsport location. Thank you.
Job Summary
This role will support validation projects with key focus around customer specification validation master plan protocols and reports. This person will provide the company with the technical and Validation resource to manage the Validation deliverables on selected projects and will coordinate the necessary activities for ensuring the timely closure of Validation activities on projects.
Essential Duties and Responsibilities
- Support Automation Tooling and Process Engineers with validation activities.
- Will be required to assist in preparing IQ OQ and PQ protocols and reports.
- Raising and writing change control requests.
- Drafting change control proposals.
- Drafting project trackers.
- Aligning the required approvers.
- Managing customer approval.
- Writing validation technical reports.
- Chairing meetings and taking minutes.
- Coordinating project timelines across all automated lines.
- Aligning all the required resources for completion of a validation project.
- Other duties as assigned.
Additional Responsibilities
Education
- Education: Associate or Bachelors Degree in engineering or equivalent on the job experience in a technical discipline to include: manufacturing industrial materials or plastics
- Knowledge of the basic principles of injection molding systematic molding mold design mold assembly and machine operations.
Work Experience
- Minimum 3 years 3 Years of experience in engineering related discipline required and
- Six Sigma and Lean Manufacturing experience required
Preferred Knowledge Skills and Abilities
- Good understanding and knowledge of validations in a Medical Device environment.
- Good understanding of computer system validation.
- Familiarity with SAP Master Control or similar systems and databases a plus.
- Must have a thorough understanding of statistics SPC and ideally the use of Minitab.
- Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.
- Must be able to prioritize and organize tasks.
- Must have excellent interpersonal & problemsolving skills & be able to interface with employees in all levels of the organization; must possess good organization timemanagement negotiating & conflict resolution skills.
- 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
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- Able to comply with the companys safety policy at all times.
- Able to comply with the companys quality policy at all times.
License and Certifications
Travel Requirements
Physical Requirements
Additional Requirements
- Selfmotivated and solutionoriented personality.
- Excellent written and verbal skills.
- Good communication project management and interpersonal skills.
- Good organizational skills.
- Effective problemsolving skills.
- Must wear safety toe shoes safety goggles and hearing protection as required in production areas.
- Must follow and comply with Plants Dress and Hygiene Code (SOI).
- Must follow and comply with all Company and Plant policies procedure (SOIs) rules and State and Federal laws
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 postoffer background screening and/or drug screening.
#LI9394
Required Experience:
IC
Employment Type
Full Time
