Engineering Manager / Associate Director
Summit Biosciences Inc. - Lexington, KY

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Reporting to executive management, the incumbent is responsible for developing and managing the Engineering, Maintenance & Metrology and Validation departments in an FDA regulated cGMP pharmaceutical manufacturing environment. This includes the comprehensive management of the current design and build activities, procurement of equipment, installation, commissioning and validation activities, hiring and development of staff and optimization of processes.

Essential Duties:

  • Manage and direct engineering, maintenance and validation departments in preparation for commercial manufacturing of multiple nasal spray products.
  • Lead the design of facilities and equipment and the optimization of existing manufacturing processes to deliver FDA compliant production capacity on time and within budget.
  • Lead the validation function to assure facilities, utilities and process equipment qualifications are performed to company standards.
  • Guide the specification and selection of manufacturing equipment/utility equipment and award architectural and engineering contracts based on comparative bids and analysis.
  • Maintain a high, and continuously improving, level of cGMP compliance to ensure patient safety and to minimize risk to the company business. Support Regulatory licensure activities, including agency inspections. Provide expertise and leadership in formulating inspection responses.
  • Motivate, recruit and develop key employees. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
  • Maximize the success rate for production operations by instituting programs to minimize mechanical failure, closed-system breaches, and procedural errors. Support strategic plans for process and plant improvements in order to increase efficiency and drive down costs.
  • Provide adequate workspace for all functions on-site through space and capacity planning.
  • Plan and manage capital plan for facility and production equipment related spending to assure production is in a position to meet new product development and product launch manufacturing requirements.
  • Assure plant preventive maintenance & metrology, , security, safety, industrial hygiene and environmental protection programs are functioning effectively and meet regulatory agency compliance requirements.
  • Leads projects such as; new equipment design and procurement, implementation of automation, identification and installation of electronic management systems, etc.
  • Optimize documentation systems for maintenance, metrology, engineering and potentially other functional areas.
  • Communicate with partners and clients in order to identify and implement any necessary equipment or capabilities for new projects.
  • Development and supervision of direct reports.

Desired Skills and Experience

  • GMP experience is a must
  • BS in engineering or relevant technical discipline
  • 10 years of experience in pharmaceutical engineering and validation related functions
  • Experience managing plant design, construction, commissioning and validation projects
  • Hands on experience in validation, equipment troubleshooting and repair, automation project management and vision systems
  • Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs
  • Financial acumen to be able to allocate and track resources which provide the highest return to the organization
  • Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems and cleanrooms, automated pharmaceutical processing and plant equipment
  • Excellent technical writing, communication and organizational skills
  • Experienced in financial and accounting principles/spreadsheets and Project Management
  • Good interpersonal skills and the ability to work well in a team environment

Please submit resume and cover letter for consideration.

Indeed - 10 months ago - save job - block