Pharmaceutical - Commissioning & Qualification (C&Q) Validation Manager

5 days ago

Greater Toronto Area Canada, Ontario MMR Consulting Full time

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. Its services include Engineering, Project Management, Validation and other Consulting services. MMR has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in the project management, commissioning and qualification, of equipment, systems and facilities. This role is based out of the Greater Toronto, ON area. Some travel is expected.

This role is for a Commissioning & Qualification (C&Q) Validation Manager to work on the commissioning, qualification, startup systems in the pharma/biotech industry. The ideal candidate should possess leadership skills to lead/mentor junior engineers.


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


Compensation: Salary starts from 100k/year + benefits

The base salary offered will be determined by the successful candidate’s relevant experience, skills, and competencies, while ensuring internal equity is maintained. Experienced candidates may be offered a higher salary range based on their level of expertise and qualifications.


Artificial intelligence (AI) is used during the screening of applications.


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.

  • Electrical Solutions Specialist

    1 month ago

    Toronto, Ontario, Canada Amp Pro Electrical Solutions Inc. Full time

    Amp Pro Electrical Solutions Inc. is seeking an experienced Electrical Solutions Specialist to join our team in providing top-notch electrical services. This full-time position offers a competitive salary of $80,000-$120,000 per year, depending on experience and location.About the RoleThe successful candidate will be responsible for designing and...

  • LEAD Validation Engineer/Specialist

    2 weeks ago

    Greater Toronto Area, Canada, Ontario MMR Consulting Full time

    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 Validation. MMR has offices in Canada, USA, Australia, Singapore and India.This is an outstanding opportunity to...

  • Associate Principal

    2 weeks ago

    Toronto, Ontario, C6A, Ontario, Canada Appficiency Inc. Full time

    Solving the most complex technology and business challenges is what Appficiency is about. As the top partner for creating the new industry benchmarks in the ERP Services, Appficiency is an Oracle NetSuite Alliance Partner with over 7 different industry and partner awards. We are a leader in both construction and manufacturing and as a top 5 Alliance Partner,...

  • PhD - Model Validation Manager

    5 days ago

    Greater Toronto Area, Canada, Ontario Hemans. Full time

    About the RoleJoin a rapidly growing analytical platform provider with a focus on end-to-end, enterprise-level risk and capital analytics for the insurance sector. The team is dedicated to offering clients comprehensive, streamlined risk and capital solutions that support strategic decision-making and asset-liability optimization.They are growing quickly due...

  • Senior Pharmaceutical Marketing Leader

    1 day ago

    Toronto, Ontario, Canada Elite Digital Inc. Full time

    We are seeking a seasoned professional to join our team as a Senior Pharmaceutical Marketing Leader. This is a perfect opportunity for an experienced, multi-skilled marketing expert who wants to thrive in a fast-paced, dynamic environment and contribute to the success of our growing digital marketing agency.Job SummaryIn this role, you will be responsible...

  • Test and Commissioning Manager

    3 days ago

    Toronto, Ontario, C6A, Ontario, Canada FCC Construcción Full time

    Build Your Career at FCC CanadaFCC is an international reference in engineering and infrastructure. Fomento de Construcciones y Contratas (“FCC”), headquartered in Spain, is the parent company of one of the world’s leading infrastructure and citizen services groups. With more than a century of history, our business portfolio is highly diversified....

  • Senior Pharmaceutical Business Development Specialist

    7 days ago

    Toronto, Ontario, Canada Teva Pharmaceuticals Full time

    We are seeking a highly skilled Senior Pharmaceutical Business Development Specialist to join our team at Teva Pharmaceuticals. As a key member of our Technical Account Management department, you will play a crucial role in building and maintaining strong relationships with our customers.About UsTeva Pharmaceuticals is a leading third-party out-licensing...

  • Pharmaceutical Enterprise Sales Representative

    4 weeks ago

    Toronto, Ontario, Canada Basetwo Full time

    Basing our success on innovation and collaboration, Basetwo is a dynamic Toronto-based startup that has gained significant traction in the Boston, New York, and Bay Area ecosystems. We are working closely with top Fortune 500 chemical and pharmaceutical manufacturers to provide their engineers with cutting-edge AI co-pilots.The RoleWe are seeking an...

  • Pharmaceutical Sales Professional

    3 days ago

    Toronto, Ontario, Canada Lock Search Group Full time

    Job OverviewLock Search Group is a National Executive Recruitment firm with expertise in various industries. We are currently seeking a driven and results-oriented Specialty Sales Representative to join our client's team in the Pharmaceutical industry.The ideal candidate will bring expertise in strategic account management, experience in pharmaceutical...

  • Marketing Campaign Manager

    19 hours ago

    Toronto, Ontario, Canada ALK Full time

    Become a part of ALK Pharmaceuticals, a global leader in allergy immunotherapy.We are seeking a dynamic and results-driven Marketing Campaign Manager to drive the development and execution of marketing tactics targeting healthcare professionals (HCPs). Reporting to the Senior Marketing Manager, this role demands strong collaboration, analytical and...

  • Electrifying Business Growth Manager

    6 days ago

    Toronto, Ontario, Canada Delta-Q Technologies Full time

    About the RoleWe are seeking an exceptional Business Development Manager to lead our expansion in North America's motive applications market.The successful candidate will drive business growth through compelling sales, strategic partnerships, and innovative solutions.ResponsibilitiesDevelop and execute a growth strategy that balances financial success with...

  • Senior Business Development Manager for Electric Vehicle Charging Solutions

    4 weeks ago

    Toronto, Ontario, Canada Delta-Q Technologies Full time

    About Delta-Q TechnologiesAt Delta-Q Technologies, we're passionate about creating sustainable business solutions and contributing to a greener future for the world. Our vision is to 'Charge The Future,' and we're committed to delivering innovative battery charging solutions that meet the evolving needs of our customers.Our ValuesPerseverance: We don't give...

  • Senior Contract Manager

    1 day ago

    Toronto, Ontario, Canada Vered Klein Recruitment Consultants Full time

    About UsWe are a dynamic full-service architecture practice dedicated to creating transformative spaces that enhance communities. Our pioneering approach has established a strong reputation for excellence throughout our extensive history.At our firm, we value innovation, collaboration, and empowerment as fundamental principles. We have developed a unique...

  • Pharmaceutical Data Management Specialist

    4 weeks ago

    Toronto, Ontario, Canada Astellas Pharma Full time

    Astellas Pharma is seeking a highly skilled Pharmaceutical Data Management Specialist to join our team in Ontario, Canada.Job OverviewThis is an exciting opportunity to work on digital transformation and make a real impact within a company dedicated to improving lives. As part of Astellas' commitment to delivering value for our patients, we are undergoing...

  • Director of Pharmaceutical Marketing

    4 days ago

    Toronto, Ontario, Canada Elite Digital Inc. Full time

    Job Overview:We are seeking a seasoned Director of Pharmaceutical Marketing to join our team at Elite Digital Inc. In this role, you will be responsible for leading our pharmaceutical marketing efforts, developing marketing strategies, and overseeing project execution.Main Responsibilities:Develop and execute marketing strategies for pharmaceutical...

  • Senior Sales Executive

    6 days ago

    Toronto, Ontario, Canada Michael Page Full time

    About Our Company">- Michael Page is a leading provider of recruitment services to the pharmaceutical industry, with a focus on packaging machinery sales."> ">The Role">- Achieve and exceed defined sales targets in the assigned territory (across Canada).">- Responsible for sales growth and business development across the region.">- Identify and develop new...

  • Data Engineer

    4 weeks ago

    Toronto, Ontario, Canada MPA Recruitment Full time

    Are you a skilled software developer with expertise in KDB+/Q looking for a new challenge?We are seeking a talented Data Engineer to join our Data Services team at a global investment management firm based in Montreal. This is an excellent opportunity to work on high-quality data infrastructure and develop your skills in a dynamic environment.Company...

  • Automotive Digital Marketing Growth Strategist

    3 days ago

    Toronto, Ontario, Canada C-4 Analytics, LLC Full time

    C-4 Analytics, LLC is a forward-thinking company that takes the guesswork out of advertising. As an Automotive Digital Marketing Growth Strategist, you will be responsible for managing the sales process from initial calls to closing business with new prospects.Our company excels at helping automotive dealerships increase sales and lower cost per acquisition....

  • Global Sales Director for Pharmaceutical and Cosmetic Packaging Machinery

    4 weeks ago

    Toronto, Ontario, Canada Michael Page Full time

    About Our ClientAs a leading manufacturer of primary and secondary packaging machinery, our client serves the pharmaceutical and cosmetic industries with innovative solutions.Job SummaryWe seek an experienced National Sales Manager to lead our sales efforts in Canada. The successful candidate will be responsible for achieving sales targets, developing new...

  • Pharmaceutical Care Specialist

    4 weeks ago

    Toronto, Ontario, Canada Cornerstone Medical Recruitment Full time

    Seeking experienced Pharmacists to excel in temporary and permanent roles at Australian hospitals. Embrace the opportunity to work full-time hours while exploring vibrant regions and rural areas across Australia.We offer various opportunities in diverse locations, including:Key Highlights:Australia-wide job placements with flexible contract lengthsAbove...