Pharmaceutical - Commissioning & Qualification (C&Q) Validation Manager
Company: MMR Consulting
Location: Bradley
Posted on: June 24, 2022
Job Description:
Pharmaceutical - Commissioning & Qualification (C&Q)
Validation Manager
Previous Pharmaceutical/Biotech experience is mandatory for this
role.
MMR Consulting is an engineering and consulting firm specializing
in the pharmaceutical, and biotechnology industries in North
America and globally. Its services include Engineering, Project
Management, Validation and other Consulting services. MMR's
Engineering expertise includes Process, Automation, Facilities
engineering. Pharmaceutical expertise includes Oral Solid Dosage,
Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing,
Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal
Antibodies).This is an outstanding opportunity to join our growing
team, where the successful candidate will work with a group of
engineers involved in the design, commissioning & qualification,
start-up and project management of various processes, systems and
facilities. The work may require working out of client's
facilities, which are typically in the Greater Chicago Area (within
one hour driving distance of Chicago). This role is primarily to be
located in Bradley, Illinois. Responsibilities
- Directly manage / lead a team of CQV engineers /
specialists
- Provide technical guidance into 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, provide updates.
- Engage other departments, as required, into 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.
- You may be involved with other aspects such as
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.
- As this position requires working on client sites, you will
need to comply with the client's safety rules including mandatory
vaccination policies for COVID-19, where applicable
Qualifications
- 8+ years of experience in commissioning, qualification or
validation of various systems within the pharmaceutical/biotech
industry.
- Some previous leadership experience is required.
- Experience with commissioning & qualification of equipment &
facilities is required.
- Validation experience such as cleaning validation, thermal
validation, mixing studies, process validation, computer systems
validation is an asset but not required.
- Previous experience in the pharmaceutical / biotech industry,
with knowledge of requirements for cGMP operations.
- 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 qualification of biotech
process equipment, such as some, but not all, of the following:
fermentation, bioreactors, downstream purification processes
(chromatography, TFF, UF) 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 complexity.
- Possess mentorship skills, to coach and develop junior and
intermediate employees.
- Engineering degree, preferably in Mechanical, Electrical or
Chemical.
- Travel may be required on occasion.
- Ability to handle multiple projects and work in a fast-paced
environment.
- Strong multi-tasking skills Send your resume to:
recruitment@mmrengineering.com
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate
diversity and are committed to creating an inclusive environment
for all employees. Our hiring decisions are based on merit,
qualifications, and business needs. We are committed to working
with and providing reasonable accommodations to individuals with
disabilities globally. If, because of a medical condition or
disability, you need a reasonable accommodation for any part of the
application or interview process, please let us know the nature of
your request.
Keywords: MMR Consulting, Joliet , Pharmaceutical - Commissioning & Qualification (C&Q) Validation Manager, Executive , Bradley, Illinois
Didn't find what you're looking for? Search again!
Loading more jobs...