10 days old

Validation Engineer

Kelly Services
Louisville, KY 40207
**Validation Engineer Manager**

Direct Hire

The Validation Manager is responsible for leading a validation team to support all validation activities at Validation activities can include equipment, instrument, cleaning, computer and process validation.

Lead the development of procedures, specifications, validation master plans and other validation and engineering related documentation. The position may participate in design, build activities, equipment procurement, optimization and troubleshooting of equipment and processes, hiring and development of staff.

Essential Duties:

1. Lead all validation activities in a hands-on approach with the validation activities ? Work on multiple validation projects simultaneously and coordinate test work

2. Lead FATs, SATs, IQ/OQ/PQs of facilities, utilities and equipment in collaboration with the Engineering and Quality teams

3. Write protocols for manufacturing, utilities, lab equipment and processes

4. Oversee validation executions work according to protocol instructions and procedures

5. Plan, coordinate and track the progress of validation project

6. Compile validation packages and assure all required documentation is accurate and complete

7. Identify and champion process improvement projects and ensure equipment and systems remain in a qualified state

8. Lead investigations related to validation deviations and assure thoroughness of investigation, documentation and closure

9. Work with QA and other groups to validate drug product manufacturing processes

10. Write, review and approve technical documents and reports such as protocols, SOPs, filing documentation and other cGMP documents

11. Train personnel to write, execute and summarize studies

12. Maintain strict deadlines to minimize impact to production and maximize equipment/process efficiency

**Qualifications Minimum:**

+ BS in Biology, Chemistry, Engineering or related science or equivalent experience

+ 5 years of validation experience in a cGMP manufacturing environment

+ Minimum of 5 years of previous leadership experience in a related field

+ Excellent working knowledge of cGMPs and regulatory requirements is preferred

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-04-30 Expires: 2021-05-31

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Validation Engineer

Kelly Services
Louisville, KY 40207

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