Senior Director, NPI Engineering

IntePros is currently looking for a Senior Director, NPI Engineering to join one of our growing Medical Device/Manufacturing clients in Philadelphia, PA. The Senior Director, NPI Engineering will lead the engineering team at our CDMO manufacturing site, overseeing all aspects of process engineering, project engineering, capacity management and capital management. This role requires a strategic leader with an understanding of Pharmaceutical and medical device regulations, a passion for continuous improvement and a commitment to quality and efficiency.

Senior Director, NPI Engineering Responsibilities

• Oversees NPI engineering project management.
• Supervises a staff of engineers and/or engineering technicians and provides guidance, leadership, and mentorship in areas of engineering, project management, and professional development.
• Prioritizes and guides engineering and project management resources in the design of new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to business plan.
• Plan and manage capital plan for facility and production equipment related spending to assure production can meet new product development, equipment commissioning, product launch, and contract packaging requirements.
• Works with global engineering to guide the specification and selection of manufacturing equipment/utility equipment and awards architectural and engineering contracts based on competitive bids and analysis developed by site Project Managers.
• Adapts NPI engineering organization to meet changing product portfolio and customer demands through appropriate hiring and organizational structuring.
• Communicates significant equipment or process issues to site leadership.
• Measure and analyze performance metrics of the NPI project portfolio, and undertake escalations to address time, cost and scope issues.
• Ensure effective communication, planning and coordination between other functions
• Prepares equipment/engineering estimates for potential projects (to be submitted to sales).
• Analyzes sales requests to determine equipment, tooling, or delivery systems needed.
• Oversee the Engineering review of all components for new jobs (size, capability of equipment, bar codes).
• Conducts and/or participates in customer meetings and attends occasional off-site meetings.
• Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering.
• Responsible for the administration, implementation, and project management of assigned projects, including using company-wide standardized methodology.
• Coordination of outside design, integration, and equipment manufacturing services.
• Manages the site facilities and utilities to accommodate new equipment and meet all regulatory requirements.
• This position may require overtime and/or weekend work. Knowledge of and adherence to all client, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.

Required

Senior Director, NPI Engineering Qualifications:

• Bachelor's Degree in Engineering or related field
• 7-10 years experience in a related industry
• College Level Mathematical Skills
• Program and Project management
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
• High standard of report writing.

Preferred

• Ability to adapt to changing work environments.
• Ability to effectively present information to various people as the job requires.
• Ability to work independently and/or as part of a team.
• Ability to display excellent time management skills.
• Lean/Six Sigma training
• GAMP5 experience with drug-device assembly processes