Biopharmaceutical Commissioning Manager
1 week ago
We are seeking a highly experienced Biopharmaceutical Commissioning Manager to join our team at MMR Consulting Inc. This is an outstanding opportunity to lead a team of engineers in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities in the pharmaceutical and biotechnology industries.
Key Responsibilities- Directly manage and lead a team of CQV engineers/specialists
- Provide technical guidance on commissioning, qualification and start-up of pharmaceutical/biopharmaceutical cGMP process equipment, utilities & facilities
- Lead the development 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, project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development, 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
- 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 URSs, DQs, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
- Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues
- 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
MMR Consulting Inc 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.
-
Biopharmaceutical Commissioning Engineer
1 week ago
Carlsbad, United States MMR Consulting Inc Full timeJob Title: Biopharmaceutical Commissioning EngineerMMR Consulting Inc is seeking a highly skilled Biopharmaceutical Commissioning Engineer to join our team. As a key member of our engineering team, you will be responsible for the commissioning, qualification, and start-up of various equipment and facilities in the biopharmaceutical industry.Key...
-
Biopharmaceutical Commissioning Engineer
7 days ago
Carlsbad, United States MMR Consulting Inc Full timeJob Title: Biopharmaceutical Commissioning EngineerMMR Consulting Inc is seeking a highly skilled Biopharmaceutical Commissioning Engineer to join our team. As a key member of our engineering team, you will be responsible for the commissioning, qualification, and start-up of various equipment and facilities in the biopharmaceutical industry.Key...
-
Biopharmaceutical Commissioning Specialist
2 days ago
Carlsbad, United States MMR Consulting Inc Full timeJob Title: Biopharmaceutical Commissioning SpecialistWe are seeking a highly skilled Biopharmaceutical Commissioning Specialist to join our team at MMR Consulting Inc. As a key member of our engineering team, you will be responsible for the commissioning, qualification, and start-up of various equipment and facilities in the biopharmaceutical industry.Key...
-
Carlsbad, United States MMR Consulting Full timeJob SummaryWe are seeking a highly skilled Biopharmaceutical Commissioning and Qualification Engineer to join our team at MMR Consulting. As a key member of our engineering team, you will be responsible for leading the commissioning, qualification, and start-up of various equipment and facilities in the biopharmaceutical industry.Key ResponsibilitiesProvide...
-
Carlsbad, United States MMR Consulting Inc Full timeCommissioning and Qualification Engineer/SpecialistMMR Consulting Inc is seeking a highly skilled Commissioning and Qualification Engineer/Specialist to join our team. As a key member of our engineering team, you will be responsible for providing technical guidance and leadership in the commissioning and qualification of various pharmaceutical and...
-
Carlsbad, United States MMR Consulting Full timePrevious 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...
-
Carlsbad, United States MMR Consulting Full timePrevious 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...
-
Biopharmaceutical SR. COMMISSIONING
2 months ago
Carlsbad, United States MMR Consulting Full timeJob DescriptionJob DescriptionSalary: Biopharmaceutical SENIOR COMMISSIONING & QUALIFICATION ENGINEER 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 Management, and other...
-
Biopharmaceutical COMMISSIONING
1 month ago
Carlsbad, United States MMR Consulting Full timePrevious 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’s Engineering expertise includes Process, Automation, Facilities engineering....
-
Carlsbad, United States MMR Consulting Full timeJob DescriptionJob DescriptionSalary: 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 industries in North America and globally. Its services include Engineering, Project...
-
Electrical Engineer
1 week ago
Carlsbad, United States Assystem Full timeJob DescriptionAssystem is a leading international company accelerating the energy transition worldwide. Our team of 6,500 experts in 12 countries is dedicated to making a difference in the energy sector. We are committed to innovation, expertise, and values that drive us to think differently about the energy transition.Main ResponsibilitiesContribute to...
-
Executive Director, Global Project
36 minutes ago
Carlsbad, United States Ionis Full timeJob Title: Executive Director, Global Project & Portfolio ManagementIonis Pharmaceuticals, a leading biopharmaceutical company, is seeking an experienced Executive Director to lead its Global Project & Portfolio Management team. As a key member of the organization, you will be responsible for driving the development and execution of global projects, ensuring...
-
Outside Sales Engineer
1 month ago
Carlsbad, United States CFM-San Diego, Inc. Full timeCompany DescriptionCFM-San Diego, Inc. is a Manufacturer’s Representative and Distributor based in Carlsbad, CA, specializing in industrial process instrumentation and controls. Our product mix addresses the needs to monitor and control the process variables of pressure, flow, temperature, level, and more. We serve industries such as Water, Wastewater,...
-
Fitness Membership Sales Associate
4 months ago
Carlsbad, United States Row House La Costa Full timeJob DescriptionJob Description Row House La Costa is currently seeking high energy, passion filled, and sales motivated individuals who are fitness minded and have a love for community, and our brand!Row House is a boutique rowing concept that strives to give people of all different fitness levels an efficient, high-cardio, full-body workout in less than...
-
Carlsbad, United States Ionis Full timeJob Title: Executive Director, Clinical Development NeurologyIonis Pharmaceuticals, Inc. is seeking an experienced Executive Director to lead our Clinical Development team in the Neurology therapeutic area. As a key member of our leadership team, you will be responsible for developing and executing clinical development strategies to bring innovative...
-
Project Manager II
3 days ago
Carlsbad, United States Dennis Group San Diego Full timeJob DescriptionWe are seeking a highly skilled and experienced Project Manager to join our team at Dennis Group San Diego. As a Project Manager, you will be responsible for ensuring the successful delivery of projects from planning through commissioning, including developing key success criteria and ensuring they are achieved.Key ResponsibilitiesManage...
-
Site Operations Manager
5 days ago
Carlsbad, United States Anaergia Full timeJob OverviewThe Site Engineer plays a crucial role in overseeing all activities on site during the construction and commissioning phases of a project. This position is site-based and responsible for providing full management and organization of all site activities until handover to the client. As Anaergia's site lead, the Site Engineer will be the primary...
-
Project Engineer
2 weeks ago
Carlsbad, United States Gahagan & Bryant Associates Inc Full timeJob DescriptionWe are seeking a highly skilled Project Engineer / Asset Management Specialist to support the onboarding and induction of new site equipment and systems for a new facility located in Carlsbad, CA.Key Responsibilities:Onboarding Systems: Onboard and induct site equipment and systems into BM-RAM (Blue Mountain RAM), including setting up and...
-
Materials Coordinator I
3 weeks ago
Carlsbad, United States Proclinical Staffing Full timeMaterials Coordinator I - Contract - Carlsbad, CAProclinical is seeking a Materials Coordinator I for a contract role in Carlsbad, CA. Primary Responsibilities:The successful candidate will focus on managing the receipt, documentation, and coordination of materials within a dynamic manufacturing and laboratory environment. The role requires attention to...
-
Fitness Studio Manager
6 days ago
Carlsbad, United States Pure Barre Full timeGeneral Manager Job DescriptionPure Barre is seeking a highly motivated and experienced General Manager to lead our studio operations and drive sales and service excellence. As a key member of our team, you will be responsible for overseeing all aspects of the studio, including sales, marketing, and customer service.Key Responsibilities:Lead generation and...
