PHARMACEUTICAL – SR. CQV ENGINEER

MMR Consulting•Irvine, CA

6d•Onsite

About The Position

MMR Consulting is seeking a Sr. CQV Engineer to join their growing team. This role involves working with a group of engineers on the design, commissioning & qualification, start-up, and project management of various processes, systems, and facilities within the pharmaceutical and biotechnology industries. The ideal candidate will have leadership skills to guide intermediate and junior engineers. The position requires validation of upstream and downstream bioprocess systems/equipment and process equipment in pharma/biotech industries. The role will primarily be based at client facilities in Irvine, California, and surrounding areas.

Requirements

Previous Pharmaceutical/Biotech experience is mandatory for this role
12+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for cGMP operations.
Engineering degree, preferably in Mechanical, Electrical or Chemical.
Ability to handle multiple projects and work in a fast-paced environment.
Strong multi-tasking skills
Ability to lift 50 lbs.

Nice To Haves

Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required.
Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset.
Experience with commissioning and qualifications of biotech process equipment, such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), CIP systems, Buffer systems, Clean Utilities would be an asset.
Experience with Qualification or Validation of clean utilities and ISO clean rooms.
Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset but not required.
Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexities.
Possess mentorship skills, to coach and develop junior and intermediate employees.

Responsibilities

Provide technical guidance in the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities.
Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle.
Able to perform field execution of qualification test cases and protocols.
Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following – Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, and provide updates.
Engage other departments, as required, in the design reviews and decisions.
Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification, and validation phases.
Visit construction and installation sites, wearing necessary safety PPE.
Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
Supervise contractors during critical testing of system and equipment.
Other duties as assigned by client, and/or MMR, based on workload and project requirements.
Comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable.
Lead/Mentor a team of validation engineers/specialists.