Process, Plant and C&Q Manager

Sanofi•Toronto, ON

2d•Onsite

About The Position

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. The Process, Plant and C&Q (PPC) Manager leads, provides leadership, direction and oversight to all external and internal Process and C&Q resources for Tier 3 (<5MEuro) capital projects and manufacturing assistance.

Requirements

Bachelor of Engineering, Science or comparable education
5+ years of relevant experience in executing and managing C&Q, construction, large projects, equipment start-up and commissioning, specifically using risk-based approaches in line with current industry best practices
Demonstrated success leading and coaching technical teams to achieve desired technical results, particularly change management within the C&Q space
Strong Knowledge of C&Q Lifecycle Approach with understanding of validation using risk-based approach
Knowledge of the pharmaceutical industry including GMP, FDA and regional/country authorities’ guidelines
Working knowledge of unit operations typically used in biotech and vaccine manufacturing, specifically downstream operations of bulk manufacturing including aseptic formulation, filling, inspection and packaging etc. is desirable
Knowledge of GxP facility finishes, process and building control systems is an asset
Knowledge of utility design (WFI, PW, clean steam, plant steam, clean compressed air, etc.) is an asset
Demonstrated success working across organizations in a highly cross-functional team environment
Demonstrated leadership experience
Critical thinking is a must with a strong desire to challenge the status quo
Excellent communication skills (written and verbal) to support interactions with senior leadership, inspectors and external vendors
Strong interpersonal skills with demonstrated stakeholder management, conflict resolution in group dynamic
Strong organizational skills and ability to deal with conflicting priorities

Nice To Haves

PMP, P.Eng or other related certifications are preferred.

Responsibilities

Lead investigations & develop CAPAs for unplanned disruptions, breakdowns, and deviations
The PPC Manager supports design, construction and mechanical completion and start-up for facility and equipment on Tier 3 projects; the incumbent will ensure C&Q planning, strategy and executions are completed meeting defined budgets and timelines
Act as an SME for quality-related discussions during audits/inspections and provide support to Capital Projects as required; ensure C&Q standards are in compliance with regulatory requirements at all times
Lead technical input on projects and cross functional support for maintenance and reliability teams on engineering aspects of existing facilities.
This position is the primary liaison with Global Engineering for all construction safety in scope of Tier 1 and 2 projects (>5MEuro) and ensures local regulations as well as Global Minimum Requirements are followed
Working with ETS RMO for robust resource planning of internal and externals to ensure projects are resourced and skilled to execute on site priorities, including where applicable statements of work and vendor selections
Strong collaboration with Project Management, Quality, Reliability, Automation, Maintenance, HSE, Operations and support functions to achieve deliverables.
Collaborate with Legal and Procurement teams to ensure protections and savings for the Toronto site in contractual relationships with external suppliers
With consideration for efficiency, safety and quality, the PPC Manager will lead department continuous improvement initiatives and identify improvement opportunities for critical systems
Represent the assigned Capital Projects and business as needed in various executive/management committees as required.
Participate in applicable COPs and support project lessons learned to share with network
The PPC Manager supports front-end studies and feasibility for Tier 1 and 2 projects from a PPC perspective
The Document Control group resides within the organization of the PPC Manager; all site drawings, project drawings, turnover packages, both GxP and non-GxP are managed by this team
Supports Site Master Planning with collection of utility data, management of site plan, drawing support, site infrastructure lifecycle management, etc.
Team development, including maintenance of skills matrices, cross functional training initiatives and routine performance review
Supports all external contractor safety training
Ensures local regulations are understood and followed on Tier 1 and 2 projects
Works in collaboration with Maintenance to ensure a robust permitting program
Responsible for SME input to HSE Construction policies on Toronto site and contributor to Global Minimum Requirements safety standards
Participates in various technical HSE assessments during the project as required; every reasonable precaution is taken to ensure the health and safety of staff and contractors
Participates in the investigation of incidents and work-related illnesses
Responds promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner
Advises staff and/or contractors of any potential or actual health, safety and or environmental hazard of which they are aware
Ensures that protective equipment and clothing required is used by staff
Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.