We provide customized solutions for all aspects of a project lifecycle (including design, procurement, installation, startup and commissioning, qualification, operation and continuous improvement) in an FDA regulated environment.  We enable customers to meet regulatory and financial objectives through the implementation of proven quality systems and process excellence strategies with the use of efficient project management.

We are looking for a high potential, energetic team player to complement our team. We offer a competitive compensation package with significant growth opportunities.

Job Description

Multiple positions available

Working with a multi-disciplinary team, the Engineer ensures completion of project deliverables according to the established plan.  The Engineer is required to be a hands on leader providing technical expertise and direction to project personnel. 

The Engineer will lead, coordinate and execute validation and engineering projects through all technical aspects of the project lifecycle.  The Engineer is responsible for the quality of work produced.

Qualifications

Minimum of B.S. in Engineering, Computer Science or Scientific discipline

Engineer II: Minimum of 2 years experience within a highly regulated environment

Sr. Engineer: Minimum of 5 years experience within a highly regulated environment

Must be able to apply knowledge of and work in a cGMP environment

Knowledge of Problem Solving, DMAIC and Lean Manufacturing tools are an asset

Must be able to commute to client sites within Los Angeles and Orange County.

Shall be results oriented with extensive hands on experience in the Pharmaceutical and/or Medical Device areas, familiar with industry concepts, practices and procedures within a cGMP environment.  Must be experienced 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, Re-qualification, etc…), and Process Excellence Methodologies (Six Sigma, Lean, etc…).

The incumbent must excel in working in a team environment with demonstrated strength in the areas of communication, leadership, client loyalty, initiative and business integrity.

Candidates local to the Los Angeles / Orange County areas only.  Relocation assistance will not be provided.