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Lead Project Coordinator

3 months ago

Montreal, Quebec, Canada Trinity Consultants - Advent Engineering Full time

Lead Project Coordinator – Facility Development

Location: Remote

Trinity Consultants - Advent Engineering is a premier engineering and consulting organization specializing in the pharmaceutical and biotechnology sectors.

With a global presence and a commitment to excellence, our firm engages in a wide array of activities related to the design and engineering of pharmaceutical and biotechnology facilities, as well as quality system projects.

Our comprehensive services encompass process engineering, automation solutions, project management, facility/system design, startup and commissioning, validation, and compliance consulting for leading biotechnology and pharmaceutical manufacturing enterprises.

The ideal candidate will collaborate with a team of engineers focused on the design, automation, commissioning, and initiation of various processes, systems, and facilities. A blend of strong technical skills, automation expertise, and proficient technical writing is essential.

Key Responsibilities:

  • Assist in the selection and appointment of designers, consultants, and internal resources to establish project teams.
  • Review project documentation including Basis of Design (BOD), User Requirement Brief (URB), and User Requirement Specification (URS), ensuring stakeholder approval.
  • Ensure contractor proposals are in alignment with BOD and URS as necessary.
  • Collaborate with design teams to create conceptual layouts and presentations for stakeholders.
  • Develop capital expenditure (CAPEX) cost plans, benchmarking against previous projects, and maintain ongoing updates of cost plans and budget management.
  • Establish programs for tracking all project deliverables (Project Execution Plan).
  • Facilitate the transition from conceptual design to tender status.
  • Conduct risk assessments, including health and safety evaluations, and maintain a risk register.
  • Generate monthly reports detailing cost, program, quality, and risk updates.
  • Compile all operational and maintenance documentation, testing certifications, and handover documents, including validation documentation as applicable.
  • Assist with asset registration and Planned Preventative Maintenance strategies.
  • Oversee verification of task completion and handovers.
  • Participate in and facilitate various meetings as required.
  • Issue directives on behalf of clients to project teams and advise on necessary decisions requiring authorization.

Qualifications:

A bachelor's or master's degree in Life Sciences, Engineering, or a related field is required, along with a minimum of 10 years of experience in the biopharmaceutical, biological manufacturing, or contract laboratory sectors.

Project management certification is preferred.

Extensive experience in providing technical support and project management services within GCLP and/or cGMP environments is essential.

Familiarity with regulatory guidance and trends in the biopharmaceutical industry (Canada, US, and EU), as well as current industry standards and best practices, is crucial.

Demonstrated experience in leading complex projects and participating in cross-functional teams is required.

Strong communication, problem-solving, and influencing skills are necessary, along with advanced technical writing capabilities.

Proficiency in Microsoft Office Suite, including MS Project, and experience in collaborative work environments are expected.