Job Listing: Sr. Process Engineer

Sr. Process Engineer Job Description:
Our client is a cutting edge company in the field of molecular diagnostics. They have two facilities in Pasadena, one of which is in need of a Senior level Process Engineer for their current and next generation DNA diagnostic products.

The Sr. Process Engineer is responsible for leading process engineering, validation and transfer activities, including coordinating process improvements activities of existing product lines, and validations for new product(s). This position will be instrumental in communicating with key decision makers and bridging the lines of communications between, quality assurance, research/development, and the commercial manufacturing departments.

Responsibilities:
-Full process engineering and validation responsibility.
-Responsible for transferring and validating raw materials, and production processes into manufacturing.
-Responsible for creating and approving Specs, Work Instructions and other documentation as part of Product Transfer for new product introductions.
-Take part in the review, audit, qualifying and selection of vendors.
-Liaison to the R&D, QA, QC, MFG, Operations.
-Work directly and in-direct with all activities of manufacturing engineering, validation, PM maintenance, including managing departmental projects and resources.
-Direct and manage all activities for Process Engineering, Controls Automation, including ramp up for manufacturing projects.
-Draft and execute documentation needed for transfer of products to manufacturing.
-Draft, submit, and execute IO, OQ, PQ protocols for production equipment and facility systems.
-Draft & submit final document packages of SOPs & validations.
-Responsible for leading project management teams as part of product transfer projects including planning, tracking and facilitating functions.
-Responsible for Design Control activities for New Product Introduction which includes creating, editing, and approving documents.
-Responsibility for feasibility studies, engineering runs, clinical and commercial manufacturing processes and products include developing quarterly and annually summary reports.
-He/she will negotiate and implement service level agreements along with key stakeholders including Quality, Regulatory, Process Development, and Operations.
-He/she will apply standard project management tools and principles to ensure project success.
-Supervise engineers and technicians as projects demand

Qualifications:
-Bachelor’s or advanced degree in a Manufacturing/Industrial Engineering discipline with at least 5 years of experience in the life science industry
-The candidate must have at least 5 years experience in design transfer from product development to commercial manufacturing processes arena.
-Experience with evaluating and transferring molded plastic components, PCBs and other consumables into manufacturing environments.
-In-depth experience with process and product validations, specification setting and test method validations, statistical process control techniques and FDA documentation.
-Project Management successes with expertise influencing key decision makers within a matrix environment
-Working knowledge of medical device cGMPs and FDA compliance


This position is located in Pasadena, CA
The salary for this position is based on experience.

Required Skills for Sr. Process Engineer Job:

About Aerotek CE:

Join Aerotek CESM, one of the leading providers of engineering and engineering support professionals in North America. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries. We know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek CE offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek CE team! Allegis Group and its subsidiaries are equal opportunity employers.