Senior Project Manager
3 months ago
Senior Project Manager – Facility Expansion
Location – Montreal, Quebec
ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.
This is an outstanding opportunity to join our growing team
Mandate:
- Scope of work will include multiple construction projects, from feasibility, design, through construction, to project completion and handover.
- Full-time, (40 hours/week) work.
- Must be able to work on-site in the Laval, QC area.
Responsibilities:
- Assist with procurement and appointment of designers, consultants, and internal client resources to form project team(s).
- Review Basis of Design (BOD), User Requirement Brief (URB), User Requirement Specification (URS), and associated schedule, and obtain approval from stakeholders.
- Ensure contractor proposals align with BOD and URS as applicable.
- Collaborate with designers to develop conceptual layout and presentations to stakeholder.
- Develop CAPEX cost plans, including benchmarking against previous CAPEX projects. Ensure continual updates of the cost plan and cost reporting, and budget management.
- Develop program(s) for capturing and tracking all project deliverables (PEP).
- Facilitate transition from concept to tender status.
- Facilitate completion of all applicable risk assessments, including health and safety.
- Develop risk register.
- Generate monthly reports capturing cost, program, quality, and risk updates.
- Collate all O&M documentation, testing and commissioning certifications and handover documents (including validation documentation, as applicable).
- Assist with asset registration and Planned Preventative Maintenance plans.
- Facilitate verification of duties completion and handovers.
- Attend and facilitate client, design, project, site and other meetings as required.
- Issue instructions on behalf of the client to project teams.
- Advise the client of any decisions require and obtain authorization.
Qualifications (Senior):
- Requires a bachelor’s or master’s degree in Life Sciences, Engineering, or related discipline, combined with a minimum of 10 years of experience in the biopharmaceutical industry, biological manufacturing industry, contract laboratory industry, or equivalent.
- Project management certification.
- Extensive experience with providing technical support and project management services for GCLP and/or cGMP environments.
- Knowledge of biopharmaceutical industry regulatory guidance and trends (Canada, US, and EU), CGLP principles, current industry standards and best practices.
- Proven experience in leading complex projects and involvement in cross-functional teams.
- Strong communication, problem-solving and influencing skills.
- Advanced technical writing skills.
- Proficiency in Microsoft Office Suite including MS Project, and experience within shared work environments.
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