Job Description
Notes from intake - Role is Equipment validation and Cleaning Validation
Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus
Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media Hold/Media Fill. Cleaning Val is mostly Drafting SOPs
Other equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient). Looking for the worker to Build Equipment Requalifications in Kneat.
- Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment.
- Drive/own the validation plans and execution of equipment changes and process improvements.
- Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
- P erfo r m E q u i p m e n t V a l i d a t i on a c t i v i t i es t o i n c l u d e V a li d a t i on M a i nt e n a n c e Q u a l i ty S ys t e ms re v i ew a n d r e q u a l i f i c a t i on to e n s ure G MP e q u i p m e n t i s c o n t i n u o u s l y m a i nt a i n e d i n a v a l i d a t ed s t at e .
- P r o g r a m, or g a n i z e, a nd m a i n t a i n V a l i d a t i o n e q u i p me nt a n d su p p l i es i n c l u d i ng d at a l o g g ers a nd p r o b e s .
- Dem o n s trate a g e n e r a l u n d er s ta n d i ng of b i o p h ar m a c e ut i c a l m a n u factur i ng e q u i p m e nt a nd v a l i d at i on p r o c e d ures fo r I n s ta l l a t i on V eri f i c a t i on ( I V /IQ ), Clean-In-Place (CIP), S t e a m- I n - P l a c e (S I P ), A ut o cl a v e s, C l e a n U t i l i t i e s, S h i p p i ng V a l i d a t i o n, T e m p e r at u r e M a p p i n g C o ntro l l e d S tor a Client R o o ms a n d E q u i p m e n t.
- De v e l o p va l i d at i on proto c o l s from p l a n s a nd e n g i n e e ri ng d o c u m e nts.
- P r o v i d e b a s i c t e c h n i c al s u p p o r t w h en re v i ew i ng a n d a p pro v i ng S O P s, P r ot o c o l s, C h a n g e C o ntro l s, Dev i a t i o n s, C AP A, e tc.
- P erfo r m as s i g n ed Q u a l i ty Sys te m s act i v i t i es w i t h i n D o c u m e n t M a n a g e m e nt S ys tem (D M S ), T r a ck W i s e Qu a l i ty S ys tem ( C h a n Client C o ntr o l, De v i a t i o n, C A P A )
- Perform other duties as assigned.
Job Sumary:
Equipment Validation Analyst
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Numbers & Facts
| Location | Portsmouth, NH |
| Industry | Staffing/Employment Agencies |
| Salary | $80 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
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