Sr Director, Engineering & Fac. & Validation

Emergent Biosolutions•Winnipeg, MB

About The Position

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. This is a term position with an anticipated end date to be determined. The role is to lead the Engineering, Facilities, and Validation (EFV) team at a site. The successful candidate will serve as a member of the Site Leadership Team and provide direct management of EFV staff. They will ensure that both site and global objectives are achieved through the support of the EFV team, deliver on site EFV objectives while implementing harmonized EFV systems and processes, and provide leadership support to other sites and global initiatives as needed.

Requirements

Minimum of 15 years of experience in a senior engineering capacity with a strong preference for experience in a biopharmaceutical environment.
Demonstrated experience leading and/or governing significant capital programs in a regulated manufacturing environment (e.g., large-scale facility expansions, infrastructure upgrades, or complex capital portfolios).
Deep understanding of validation lifecycle principles, including commissioning, qualification, continued process verification, and validation program governance in cGMP environments.
Technology/Equipment (Drug Product/Drug Substance/Clinical/Commercial/Stainless Steel/Single Use) emphasis will vary by site, candidate is expected to be able to guide site to top quartile operational safety, efficiency, and reliability for these technologies.
Ability to lead at both strategic and operational levels, translating enterprise objectives into executable site and functional plans.
Highly effective verbal and written communicator at all levels of the organization.
Demonstrated ability to effectively prioritize and coordinate activities.
Proficiency in Microsoft Office applications.
BS in Engineering, Science, or Management or equivalent experience.

Nice To Haves

Licensed Professional Engineer (PE, CFM, PMP) or advanced technical or business degrees a plus.

Responsibilities

Provide leadership and direction to EFV team members, driving performance to the site and function operational and strategic plans, while establishing governance, performance expectations, and accountability aligned with organizational EFV strategy and standards.
Ensure effective systems, processes, and governance are in place to deliver maintenance, facilities, validation, engineering, EHS and protective services activities in a compliant, reliable and efficient manner.
Oversight of the full validation lifecycle (commissioning, qualification, and continued).
Own and ensure execution of the site Validation Master Plan (VMP), including alignment with global standards and integration with capital projects, operations, and quality systems.
Provide leadership oversight of validation-related quality systems, including change control, deviations, CAPA, and periodic review processes, ensuring compliance and continuous improvement.
Establish and drive risk-based validation strategies to ensure compliant, efficient, and scalable validation approaches aligned with regulatory expectations and industry best practices, processes and consistent with cGMP requirements.
Ensure adequate resourcing (capacity and capability) to accomplish site and EFV objectives including proactive workforce planning and alignment to capital and operational priorities.
Drive on-going development of the EFV team and the personal development of EFV team members, and build organizational capability to support current operations and future site and network growth.
As a Site Lead Team Member, interface with senior internal stakeholders, external partners and regulatory agencies to represent EFV capabilities and ensure alignment and delivery on strategy and operational priorities.
Own governance and delivery of the site master plan, 5-year and annual capital portfolio, including prioritization, resource allocation, and performance against cost, schedule, and scope targets, consistent with site master plans and long-range planning objectives.
Lead and influence cross-site EFV harmonization initiatives, ensuring adoption of best practices and consistent execution at the site and network level.
Escalate issues though site and/or function management as appropriate, and serve as the senior EFV escalation point for complex technical, operational, and capital-related issues.
Continuously improve the culture of the EFV team and the site including driving engagement, accountability, and a high-performance culture aligned with company values.
Actively shape and influence EFV functional strategy, providing input and leadership on priorities, investments, and performance improvement initiatives.
Lead and/or support strategic opportunity evaluations, including site expansions, new capabilities, and major capital investments.
Serve as the senior EFV representative during regulatory inspections and audits, ensuring inspection readiness and compliance across engineering, facilities, and validation systems.