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West Pharma Validation Technician United States, Pennsylvania, Williamsport 892410867
17.04.2025
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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.
- Co-ordinating project timelines across all automated lines.
- Aligning all the required resources for completion of a validation project.
- Other duties as assigned.
Education
- Education: Associate or Bachelor’s 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 & problem-solving skills & be able to interface with employees in all levels of the organization; must possess good organization, time-management, 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 company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
Physical Requirements
Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.
Additional Requirements
- 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.
- Must wear safety toe shoes, safety goggles, and hearing protection, as required, in production areas.
- 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
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