Process Validation Engineer

EPM Scientific are currently on the search for 4 candidates to fill roles as a Cleaning and Process Validation Engineer.

Planned Start date of ASAP as a W2 Contractor on a 6 - 12 month contract located in Los Angeles, CA

Details below:

Process Validation Engineer

· Ensure that all qualifications and validations are performed according to the regulatory and customer requirements

· Be able to support Quality by Design on the drugs to be transferred or developed on the site

· Write qualification and validation protocols/reports and other documentation related to the activities

· Validation of aseptic process (formulation, filling, holding times)

· Participate to shutdown qualification & calibration activities

· Investigate deviations as needed and execute corrections

· Define and execute improvement projects and initiatives

· Ensure that all activities are performed in time and due quality

Qualifications

· BS in Engineering, Science or equivalent technical degree.

· 2-5+ years' experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.

· Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).

· Excellent written and verbal communication skills; excellent technical writing skills.

· Strong interpersonal skills and the ability to work in a team environment.

· Ability to work effectively in a fast paced multitasking environment.

· Strong working knowledge of FDA and cGMP regulations and documentation practices.

· Proficient in Microsoft Word, Excel, PowerPoint.

· Working for multiple clients through out the region.


Cleaning Validation Engineer:
· Draft cleaning validation protocols and final reports

· Perform cleaning validation execution

· Support cleaning validation activities for a variety of client projects such as: a new product transfer into facility, facility capacity increase and process change support.

· Experience with glass and parts washers, CIP skids, COP

· Experience with manufacturing equipment CIP cycles and cycle development

· Experience with CIP/COP of vessels, tanks, etc.

Qualifications

· Engineering Degree required.

· 2-5 years experience with cleaning validation in a regulated environment

· Working knowledge of FDA and cGMP regulations and documentation practices.

· Excellent written and verbal communication and technical writing skills.

· Proficient in Microsoft Office Suite and able to learn new computer applications.

· Must be results oriented with hands-on experience with validation execution, familiar with industry concepts, practices and procedures in a cGMP environment


If either role interests or you feel as if you could do both roles, please get in contact with up to date resumes and expect to hear back on Friday!

Kind regards,