Technical Service Manager

Role Description

CPL require and experienced Technical Services Manager for a start up Pharmaceutical facility in the Midlands. You will be required to own equipment  and processes on site, overseeing validation and process engineering of a sterile facility. 

The Technical Services Manager is accountable for the overall Aerie Ireland manufacturiing plant Engineering and Maintenance functions, including Engineering Team Leadership, Process Engineering, Validation Engineering, and Automation Engineering.  This position is responsible for the proper installation, validation and functioning of manufacturing equipment, facility equipment, and equipment-related processes. The Technical Services Manager reports to the site’s Operations Director.

 

The Technical Services Manager is responsible for managing the Process Engineering, Validation Engineering, Automation Engineering, and Facility Maintenance functions within the Aerie Ireland manufacturing facility.  More specifically, key responsibilities include:

  • Leadership of the Engineering organization, including the development of organization structure, and the hiring, training, and management of the engineering staff.
  • Management of Process Engineering, Validaton Engineering, Automation Engineering and Facility Maintenance functions.
  • Management of design, installation, validation, operation, training, documentation and maintenance of manufacturing equipment and facility equipment, including but not limited to: filling and packaging machinery, autoclaves, boilers, water purification equipment, air handling equipment and compounding equipment. 
  • Management of equipment-related processes, including but not limited to water systems, controlled manufacturing environments, plant steam supply, clean steam supply, and sterilization processes.
  • Management of automation systems associated with facility or manufacturing equipment.
  • Ensuring that equipment and processes meet safety requirements and GMP requirements.

 


Skills/Knowledge Required: 

  • In-depth knowledge of mechanical engineering and facility-related engineering principles.
  • Knowledge of pharmaceutical validation principles and practices, as they apply to both equipment and processes.
  • In-depth knowledge of aseptic processing practices and procedures, as well as sterilization systems and procedures.
  • In-depth knowledge of equipment and processes that support pharmaceutical  production, including WFI systems, air handling systems, environmental control systems, and automation systems.
  • Knowledge of applicable regulations, including those affecting safety compliance, GMP compliance, environmental protection, and compliance with engineering standards.
  • Strong leadership skills.
  • Strong communication and interpersonal skills.

Education Required:

  • Requires a Bachelors Degree in an Engineering discipline. 

Experience Required:

  • At least 8 years? relevant experience in a pharmaceutical manufacturing environment, with at least __4?__ years experience in a comparable engineering management role.
  • Must have experience working in a sterile manufacturing environment. Ophthalmic manufacturing experience a plus.
  • New facility start up experience desired.
  • Demonstrated ability to build a high-performing team.
  • Proven track record of building and developing a technical team
  • A proven track record in enhancing technical capability and developing technical resources to SME level.
  • A proven track record in developing process control strategies that support high performing aseptic manufacturing site.

Lean principles and early adoption of same to enhance start-up delivery and future operational robustness/effectiveness.

SALARY & BENEFITS

Negotiable - depending on experience

 

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