Director in Bankruptcy Consultation & Facilitation at PwC managing complex bankruptcy risks. Leading teams, enhancing legal knowledge, and driving operational improvements in a fast - paced environment.
About the role
- 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
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- flexible work
- generous paid time off
- paid holiday
- wellness and transportation benefits
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