|Reference # : ||17-00337
||Title : ||****Validation Engineer ( BMS, Mgf and Lab)|
Morris Plains, NJ
|Position Type : ||Contract|
|Experience Level : ||
||Start Date / End Date : ||03/27/2017 / 06/30/2017
| Description |
Location: Morris Plains NJ
Job Title: Validation Engineer
Start Date: March 27th- 3 to 6 months could go longer
Our customer is one of the largest Pharmaceutical Companies in the world.
Job Opportunity: This customer is looking for an Equipment Qualification/Validation Engineer (with CSV)
6-10 years of Facilities and Manufacturing systems qualification exp.
You will be part of a new Client Implementation (Siemens) so some experience with Client systems is needed. There will be possible work with commissioning of HVAC's as well
Candidate should also have experience with lab instruments- microplate, counters, microscopes type equipment etc- (no HPLC/GC, autoclave needed) This is important for other project work happening at the plant that may need assistance, There may be some Hospital based equipment as well
Experience in aseptic manufacturing/facility assets
Duties will also incluse Computer systems Validation related to the equipment.
Will be involved in new and old systems qualification work
Equipment Qualification Consultant role may include, but may not be limited to:
Using templates, write Quality Functional Risk Assessments (QFRA's) for all equipment undergoing qualification.
Using templates write and execute qualification protocols, including IQ, OQ on manufacturing equipment/instruments.
Using templates, write final reports for qualification activities.
Write and assist in execution of Room Static and Dynamic Performance Qualifications, including final reports.
Write/investigate/assist in solving deviations.
May do some commissioning and Periodic review type wor
Prefer local candidate
Energetic- self-motivated- problem solver
Must be able to start right away ( within a week)
3-6 month assignment -could go longer
RCM is a recognized national leader in IT and regulatory compliance services providing a broad range of consulting and management services to pharmaceutical, biotech and medical device manufacturers. The unique combination of our IT, Regulatory, and Engineering Practices brings an unparalleled breadth of knowledge and experience to our clients.
RCM maintains a dedicated Life Sciences Practice that consistently reevaluates the market to determine areas of improvement. Our practice leaders constantly challenge ourselves to bring "true savings? whether through cost reduction or by reducing a products time to market.
We look forward to hearing from you!