Oakland-Fremont-Pleasanton Metro Area, CA
Primary responsibility is to oversee the facility re-validation in support of a larger project to move a production lab from one building to another. The expected work will consist of writing validation protocols in accordance with company templates and norms, coordinating with Facilities personnel and outside vendors to ensure proper execution of the protocols, and completing validation reports on all activities.
The contractor will interact with both internal partners and external vendors. That interaction requires good communication, both oral and written, and keen analytical skills in identifying potential issues before they arise. Due to the compressed timeline of the project, effectiveness in this role also requires experience in conducting similar validations and familiarity with the testing involved in those validations.
In Scope Validation Work:
tHVAC system (airflow, particle counts)
tCompressed gas (Ar, N2, CDA) lines
tElectrical (verification and mapping)
tRoom schematics (electrical, piping, HEPA locations)
tMay also assist with equipment re-qualifications (IQ/OQ/PQ).
tBachelors or Master s degree in Chemical Engineering, Mechanical Engineering, Biochemical, Bioengineering, or related field required.
tRequires BS 2-5 years or MS 1-2 years with relevant engineering experience
tPrior experience with facilities qualifications in an ISO13485 environment
Prior experience with equipment qualifications (IQ/OQ/PQ)