Validation Engineer in Millersburg, PA at Volt

Date Posted: 1/2/2020

Job Snapshot

Job Description

Volt Workforce Solutions is looking for a Validation Engineer for our amazing client in Millersburg, PA. We are seeking someone who is looking to grow into a new career.

The candidate in this position report to the Engineering Manager and is responsible for equipment and machine support that ensure manufacturing can meet production targets. 

  • Pay Rate: $31.00
  • Job Title: Validation Engineer
  • Location: Millersburg
  • Shift: 1st Shift | 6:30 am – 3:30 pm

If you are interested in this role and would like to learn more, please call the on-site recruiter.

Cass 717-382-6682

Why will you do in this role?

  • 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 on-hold 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 bio-process containers, apply statistical methods, risk assessments, DOE’s, 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, CAPA’s, 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.

How will you get here?

  • B.S. in Engineering, Physics, or a related scientific discipline
  • Lean Six Sigma Green Belt or Black Belt desired
  • 5 years of hands-on 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.
  • Self-motivated, 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.

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.

Volt is an Equal Opportunity Employer. We are committed to equal treatment of all employees without regard to race, national origin, religion, gender, age, sexual orientation, veteran status, physical or mental disability or other basis protected by law.