- 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
- 12+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
- 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
-
Receptionist (M/F/X) in part-time
3 weeks ago
Horizon Group Ulm, AR, United States FreelanceCompany Description · As an independent and interdisciplinary group of companies, we have been developing innovative business fields in the areas of security, law, real estate, events, and education since 1993. · With over 1,200 employees in more than 30 companies, BERBUS ALLIANC ...
-
IT specialist system integrator
3 weeks ago
Cascade Enterprises Holly Grove, AR, United States FreelanceSCADA-Automation is a system integrator for control system and automation solutions in industrial plants for energy generation and production, as well as energy management in companies. · We handle the project planning and implementation of control and automation systems, monitor ...
-
Interim Management Nursing Service Director
3 weeks ago
Diamond Dynamics Almyra, AR, United States FreelanceInterim Management Nursing Director (m/f/d) in Almyra, AR · We are currently seeking a motivated and travel-ready interim manager as a nursing director (m/f/d) for our client, a modern provider in elderly care in Almyra, AR. If you have previous experience as a nursing director a ...
-
MMR Consulting Carlsbad, United StatesPrevious Pharmaceutical/Biotech experience is mandatory for this role. · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR' ...
-
Resident Care Director
2 weeks ago
ISL Employees, Inc. Carlsbad, United StatesResident Care Director · $5,000 Sign-On Stay-On Bonus · Vibrant community. Inspiring company culture. · The mission of making tomorrow better than yesterday. Join ISL in making dreams come true · SUMMARY of Duties · The Resident Care Director is responsible for coordinating re ...
-
Solomon Page Carlsbad, United StatesOur client is looking to fill the role of Executive Director, Head of Safety/Pharmacovigilance. This position is hybrid and based out of the Carlsbad office. · Responsibilities: Position will lead as Deputy to Head of Safety and Pharmacovigilance Department with full oversight o ...
-
Office Manager
2 weeks ago
Alita Ameneyro - State Farm Agent Carlsbad, United StatesROLE DESCRIPTION: · As an office manager with Alita Ameneyro State Farm Insurance Agency, you equip our agency to continually achieve its goals. You empower our agency by implementing and supporting office policies and consistently ensuring the execution of advantageous customer ...
-
Laboratory Technician I
4 days ago
TechDigital Corporation Carlsbad, United States· Description/Comment: · The Technician is part of an assembly team responsible for the manufacturing of specific chemistries used in the medical diagnostics field. This role is critical to the healthcare industry and is critical to allow doctors and lab technicians to quickly a ...
-
Production Kitter Shipper
2 weeks ago
Eastridge Carlsbad, United StatesJob Description · Job DescriptionEastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. We are urgently seeking a motivated individual who can support the Productio ...
-
Med Aide
1 day ago
La Marea Senior Living Carlsbad, United StatesJob Description · Job DescriptionMedication Aide · $500 Sign On Stay On Bonus · Flexible Hours · Vibrant community. Inspiring company culture. · The mission of making tomorrow better than yesterday. Join ISL in making dreams come true · SUMMARY of Duties · The Medication Aide ...
-
MMR Consulting Carlsbad, United StatesJob Description · Job DescriptionSalary: · Previous Pharmaceutical/Biotech experience is mandatory for this role. · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Man ...
-
Service Engineer
5 days ago
Diakont Carlsbad, United StatesJob Description · Job DescriptionCOMPANY: · Diakont is part of a global group of companies dedicated to designing and manufacturing advanced products and robotics, and suppling specialty technical services that enhance safety and improve efficiency within the energy industry. Dia ...
-
Formulation Technician II/III
5 days ago
Argonaut Manufacturing Services Carlsbad, United StatesJob Description · Job DescriptionCorporate Overview · Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving ...
-
Bioprocess Technician II/III
5 days ago
Argonaut Manufacturing Services Carlsbad, United StatesJob Description · Job DescriptionCorporate Overview · Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving ...
-
Shipping Coordinator
1 week ago
Eastridge Carlsbad, United StatesJob Description · Job DescriptionEastridge Workforce Solutions is a leading provider of workforce management solutions, dedicated to connecting skilled professionals with rewarding opportunities. Eastridge Workforce Solutions is looking to hire a Shipping Coordinator to join our ...
-
sr. commissioning
5 days ago
MMR Consulting Carlsbad, United StatesJob Description · Job DescriptionSalary: · SR. COMMISSIONING & QUALIFICATION ENGINEER/SPECIALIST · Previous Pharmaceutical/Biotech experience is mandatory for this role. · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology ...
-
Project Safety Coordinator
5 days ago
Nevell Group Carlsbad, United StatesJob Description · Job DescriptionSalary: $68K-$78K · PROJECT SAFTEY COORDINATOR · This position is responsible for assisting in the execution of Safety initiatives, under the direction of the Director of Safety. Successful candidate will coordinate and lead the safety team and co ...
-
Toxicologist, Cell
5 days ago
Pharmaron Carlsbad, United StatesJob Description · Job DescriptionPosition: Toxicologist · Department: Cell and Gene Therapy · FLSA status: Exempt · Location: Carlsbad, CA · Position Description: · We are seeking a highly skilled and experienced Toxicologist to join our team of experts. The ideal candidate will ...
-
Manufacturing Technician II or III
5 days ago
Argonaut Manufacturing Services Carlsbad, United StatesJob Description · Job DescriptionCorporate Overview · Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving ...
-
Sr. CRM Business Analyst
2 weeks ago
Fluidra North America Carlsbad, United StatesJob Description · Job Description Fluidra's looking for a Senior CRM Business Analyst to join our team in Carlsbad, CA. This is an onsite opportunity. · WHAT YOU WILL CONTRIBUTE · As a Sr. CRM Business Analyst, you will be responsible for facilitating alignment of business proce ...
Biopharmaceutical - SR. Commissioning & Qualification (C&Q) Manager - Carlsbad, United States - MMR Consulting
Description
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.
Responsibilities
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.
