Senior Validation Engineer; CQV

Position: Senior Validation Engineer (CQV)
About the job Senior Validation Engineer (CQV)

Senior Validation Engineer (CQV)

Type:
Contract

Duration: 6+ months with possible extension

Location: onsite in Thousand Oaks, CA

Pay:
Hourly; DOE

Please note that at this time we are unable to sponsor employment authorization (both new and transfer)

Project Overview:

Our client is a large pharmaceutical manufacturer looking for additional validation support for an ongoing tech transfer. Currently they are duplicating an existing process which will require installation of large process equipment for fractionation. The equipment consists of buffer vessels, centrifuges, filter presses, and CIP skids. This consultant must have experience writing and executing protocols and final report for this type of equipment.

For this installation they will need someone who has qualified cleanroom facilities and their utilities in the past, HVAC and EMPQ in particular. Personality and communication skills are highly important to this team.

Key Responsibilities:

• Must have written and executed protocols and written final reports for equipment at manufacturing scale
• Construction walks to check equipment status and pre-check P&
• Protocol, design document and SOP drafting
• TOP and submittal review against specifications

Requirements:

Authoring/Executing protocols for large process equipment (Vessels, Centrifuges, Filter Presses, and CIP Skids)

HVAC with EMPQ(Environmental Monitoring Performance Qualification) of new clean rooms

Software:
Delta V, KNEAT, Veeva, Bluebeam, MS365 (Excel, Word, PPT)

Must be able to read a P&

Must be able to hit the ground running, collaborate well with the team and be hands on, not looking for someone to reinvent the wheel

Project does not approve OOO for more than 5 consecutive days

Must be able, with 3-5 days notice, work any shift including holiday

We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs