Senior Director overseeing capital projects for Just Evotec Biologics' GMP Manufacturing plants and laboratories. Collaborating with multiple functions to ensure regulatory compliance and optimal functioning.
Responsibilities
Develop JEB’s long-term facility and capacity planning in line with corporate growth strategy
Provide significant input on yearly capital equipment spend.
Work with finance to develop ROI cases as needed
Own and Eexecute various capital projects. This includes creation of a business case, feasibility, design and construction as applicable
Provide ongoing oversight for contractors, contingent workers and/or workforce needed to execute the various capital projects
Direct multiple functional teams including capital projects, facilities engineering, and validation with a matrixed organization
Lead the capital projects review board to ensure appropriate governance and execution per JEB strategy and represent facilities in various corporate planning and strategy discussions; serve as key interface between the capital project and senior leadership
Partner with the Finance team to plan and manage cash spend and commitments for the various capital projects; own capital project budgets as appropriate
Provide plant utilities commissioning, qualification, and validation, including risk assessments, user requirement specifications, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reports
Requirements
Bachelor’s degree in engineering or related science with 15+ years relevant experience; construction project management degree preferred; equivalent work experience may be considered
Demonstrated experience delivering capital projects in the cGMP biopharmaceutical sector
Experience in leading all aspects of capital projects, including budgeting, design, construction, commissioning, and validation.
Operational engineering experience and knowledge of building systems including mechanical, electrical and plumbing (MEP), HVAC, fire/life safety, waste management, and quality assurance needs/requirements
Strong knowledge of biologics manufacturing equipment and dedicated utilities systems, including but not limited to HVAC, WFI, pure steam, clean compressed air, process gases, chilled water, boilers, and wastewater treatment
Understanding/base knowledge of US FDA CFRs including ICH guidelines
Working knowledge of Quality Assurance standards, including risk assessment, and experienced in the use of electronic systems such as QMS and CMMS
Previous experience directing teams within a matrixed organization and/or managing individuals, work groups, and project teams
Motivated, self-starter with ability to operate in a fast-paced environment
Strong interpersonal, team, and communication skills are a must
Strong computer skills including Microsoft Office (Word, Excel, PowerPoint, and MS Project)
Benefits
discretionary annual bonus
comprehensive benefits to include Medical, Dental and Vision
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