BioSpace
Director, Engineering & Maintenance
BioSpace is seeking a Director of Engineering and Maintenance with a comprehensive understanding of engineering, manufacturing, quality, automation, and maintenance in the pharmaceutical industry. The role is a member of the Site Lead Team and works closely with stakeholders on site initiatives, equipment acquisition, and CAPEX projects.
Responsibilities
Accomplishment of investment projects according to customer needs (time, cost, functionality). Interface with Project Management, manufacturing, M&ST, and Quality Assurance.
Meet agreed upon budget and ensure compliance goals are met.
Evaluate critical utilities requirements to support site activities.
Minimize asset life‑cycle costs.
Provide management leadership and oversight to engineers, maintenance, facilities, and automation teams.
Oversee Maintenance, Facilities and Calibration activities.
Lead major CAPEX processes or equipment projects as required.
Provide technical support to the manufacturing group as required.
Fulfill responsibilities as a member of the DCR, Deviation and CAPA team.
Oversee design and installation of production tooling and equipment.
Provide technical support for evaluating and resolving CAPAs.
Responsible for department budgeting, equipment purchases, and project planning.
Evaluate testing and manufacturing equipment to recommend purchases for use in manufacturing.
Ensure availability of competent, high‑performing people and manage the engineering talent pool; stay abreast of emerging technologies to support high‑volume, high‑yield, high‑value aseptic operations.
Other duties as assigned by the immediate supervisor.
Required Knowledge, Skills and Abilities
Ability to function well in a team environment.
Extensive interfacing with equipment manufacturers and diverse vendors.
Excellent oral and written communication skills.
Strong cross‑functional interfacing.
Well‑rounded engineering and project management experience.
Superior analytical and computer skills.
Capable of using sound judgment to make and defend recommendations.
Proficiency in Windows, Word, Excel, AutoCAD 14, SolidWorks, Microsoft Project, etc.
Required Education and Experience
Bachelor of Science Degree in Engineering or equivalent.
15 years of engineering experience in the pharmaceutical industry.
7 or more years of experience managing an engineering team, maintenance, and facility management.
>5 years of GMP experience, including aseptic processes and clean utilities.
Demonstrated responsibility for CapEx and maintenance budgets exceeding $3M.
Target base salary $200,000 - $230,000
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Responsibilities
Accomplishment of investment projects according to customer needs (time, cost, functionality). Interface with Project Management, manufacturing, M&ST, and Quality Assurance.
Meet agreed upon budget and ensure compliance goals are met.
Evaluate critical utilities requirements to support site activities.
Minimize asset life‑cycle costs.
Provide management leadership and oversight to engineers, maintenance, facilities, and automation teams.
Oversee Maintenance, Facilities and Calibration activities.
Lead major CAPEX processes or equipment projects as required.
Provide technical support to the manufacturing group as required.
Fulfill responsibilities as a member of the DCR, Deviation and CAPA team.
Oversee design and installation of production tooling and equipment.
Provide technical support for evaluating and resolving CAPAs.
Responsible for department budgeting, equipment purchases, and project planning.
Evaluate testing and manufacturing equipment to recommend purchases for use in manufacturing.
Ensure availability of competent, high‑performing people and manage the engineering talent pool; stay abreast of emerging technologies to support high‑volume, high‑yield, high‑value aseptic operations.
Other duties as assigned by the immediate supervisor.
Required Knowledge, Skills and Abilities
Ability to function well in a team environment.
Extensive interfacing with equipment manufacturers and diverse vendors.
Excellent oral and written communication skills.
Strong cross‑functional interfacing.
Well‑rounded engineering and project management experience.
Superior analytical and computer skills.
Capable of using sound judgment to make and defend recommendations.
Proficiency in Windows, Word, Excel, AutoCAD 14, SolidWorks, Microsoft Project, etc.
Required Education and Experience
Bachelor of Science Degree in Engineering or equivalent.
15 years of engineering experience in the pharmaceutical industry.
7 or more years of experience managing an engineering team, maintenance, and facility management.
>5 years of GMP experience, including aseptic processes and clean utilities.
Demonstrated responsibility for CapEx and maintenance budgets exceeding $3M.
Target base salary $200,000 - $230,000
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