Validation Engineer
Validation Engineer
Posted on :
04-09-2024
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Posted on :
04-09-2024
Job Description
Job Title: Validation Engineer
Location: Millersburg Pennsylvania
Job Description:
- 35 years of handson validation experience with the development and execution of FAT SAT and IQ/OQ protocols.
- Leading project qualification executions from start to close out/production implementation.
- Selfmotivated proactive and capable of adhering to strict deadlines.
- Experience with clean room requirements and protocols.
- Preferably 5 years experience in the biotech or pharmaceutical sector.
- Focus on the top priorities Safety Quality Delivery and Productivity/Cost.
- Assessing and defining assigned validation project deliverables.
- Writing reviewing and execute of project validation protocols for standard & customized systems.
- Lead qualification executions working closely with customers during factory acceptance test (FAT) and site acceptance test (SAT).
- Raise discrepancies root cause discrepancies and close out test documentation.
- Prepare validation summary reports for executed protocols.
- Conduct deviation investigations such as validation failures complaints and onhold investigations. To identify & implement the appropriate corrective actions.
- Troubleshoot manufacturing equipment and process technical issues and execute corrective actions.
- Work in establishing validation processes maintaining processes and process documentation. Including but not limited to equipment machines components and bioprocess containers apply statistical methods risk assessments DOEs validations FAT SAT IQ and OQ qualifications write/review detailed technical reports.
- Work collaboratively with Operations and Quality to schedule and complete initiatives.
- Support appropriate site personnel with problem solving techniques to diagnose production issues to meet manufacturing company and customer needs.
- Actively engage in customer complaint investigations CAPAs failure investigations and problem solving.
- Proactively communicate project status issues & risks to the project team and to various levels of facility business unit and divisional management.
- Engage in the Practical Process Improvement (PPI) process developing and leading a continuous improvement culture and achievement of waste reduction goals.
- Other duties as defined within the scope of the position.
- The position reports to the Engineering Manager and is responsible for equipment and machine support that ensure manufacturing can meet production targets.
Knowledge Skills Abilities:
- Ability to flex schedule to cover 2nd shift.
- Attention to detail and ability to identify and remediation issues found during testing.
- Highly effective verbal and written skills including technical authorship.
- Proficient in Microsoft Office Word Excel and MiniTab or other statistical application.
- Must be able to manage and lead change.
- Must have a bias for action and a continuous improvement mindset.
- Strong project management and organizational skills.
- Must be capable of resolving complex problems.
- Strong problem solving mindset and analytical skills.
Education:
- B.S. in Engineering Physics or a related scientific discipline
- Lean Six Sigma Green Belt or Black Belt desired.
Employment Type
Full Time
Key Skills
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