Director, Engineering & Technical Services

Reference IDMed007
TypePermanent
Specific Duties and Responsibilities:
We are a very dynamic specialty pharmaceutical company currently manufacturing over 100 million units using fully automated syringe lines. Now we are in our next progressive growth mode; aggressively developing ANDAs, NDAs for small molecules injectable product including peptides - solution, lyophilized product, suspensions, and liposomal formulations.

The position will support the development of a new, state-of-the-art manufacturing facility that will bring additional capacity for its injectable products packaged in liquid and freeze dried vials, syringes and bags. 

The position will lead construction and start-up of a state-of-the-art manufacturing facility that will provide additional capacity for testing, formulation, fill and finish operations. The incumbent will provide construction management and facility operations perspective throughout the design, construction and CQV (commissioning, qualification and validation) phases of the program. The position will lead the staffing, development and management of the internal& external engineering, validation, technical services and maintenance staff and manage day to day operations once the facility is in commercial production. Responsible for compliance with all internal policies and external regulations governing construction execution and facility operations.

Responsibilities include:
  • Responsible for development of scope and identification of processing equipment and facilities required for aseptic manufacturing.
  • Responsible for preparation of cost estimates, equipment URS (User Requirement Specifications), selection, purchase, installation, commissioning and validation of facility and processing equipment.
  • Establishes and is accountable for all relevant deliverables including schedule milestones, financial performance and quality of scope according to approved project. 
  • Ensures that resources needed to lead/support projects are available through close partnering with senior leadership and stakeholders. 
  • Responsible for quality, safety and operating performance of all facility/site construction and operations, including compliance with all applicable specifications, Standard Operating Procedures and federal, state and local regulations.
  • Demonstrated experience leading significant capital projects in a manufacturing environment to successful completion.
  • Hands on experience in installation, start up and validation of aseptic processing equipment such as autoclaves, depyrogenation, injectable filling, capping, inspection and packaging equipment. Freeze drying experience is preferred.
  • Demonstrated experience in managing a direct engineering, facility maintenance and validation staff.
  • Demonstrated experience successfully managing external project/ construction management contractors. 
  • Experience with quality systems and processes in a FDA regulated manufacturing environment. 
  • Strong interpersonal and problem solving skills - able to communicate effectively with internal and external stakeholders (verbal and written). 
  • Demonstrated leadership effectiveness - able to effectively negotiate and influence others (internal and external) in a cross-functional organization.
Required Competencies:
Education Minimum / Recommended:

  • BS in relevant engineering discipline. 
  • Master�s degree will be a plus.

Work Experience Required:

  • Ten to Fifteen (10 to 15) years of hands on experience in engineering, facility maintenance and validation in injectable manufacturing. 
  • 7 to 10 years of leadership experience.

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