Technical Services & Process Manager

Role Description

CPL require and experienced Technical Services & Process 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. 

Reporting to the Engineering Director, the Technical Services & Process Manager  is accountable for developing and executing plans for the installation and validation & of equipment and processes at a finished drug product facility under construction in Ireland. You will also provide technical support for technical and product transfers on site, working to ensure products are produced to the highest standard in lign with international requirements. 

  • Build process engineering capability in aseptic fill finish and lyophilisation technologies and develop SME capability across the sites’ drug product technology platforms.
  • Ensure the site keeps abreast of technology enhancements to ensure manufacturing technologies remain current with best practice. 
  • Maintain a strong Governance process for technology transfer to enable alignment on progress and risk management.
  • Collaborate with Quality for effective analytical technology transfer as part of overall program.
  • Support process & technology design and associated commissioning and qualification activities including process validation.
  • Develop and implement statistical process control monitoring systems for product critical process parameters (CPPs).
  • Use data from process monitoring, statistical process control and process capacity modelling to support robust decision-making and plans for continuous improvement activities.
  • Lead the site’s operation control strategy.
  • Develop and lead the process engineering, technical operations and program management components of technology transfers and new product introductions.
  • Lead the technical input in to site periodic product review to ensure that the process is a robust assessment of process control.
  • Build a site statistical capability to support site requirements in this area.
  • Play a full part in the site’s lean program and in particular a continuous improvement focus on our manufacturing and inspection processes.
  • Support/Lead significant site technical/batch investigations.
  • Interface between process development scientists and d operations.
  • Technical point of contact with drug substance manufacturing sites and build relationships with these sites in support of product life cycle activities.
  • Recruit and train an internal technical services team. Provide leadership and development of the staff.
  • Plan internal and external technical services resources to ensure projects are completed in a timely manner, on budget and department goals are achieved.
  • Assist in developing department budgets. Champion potential facility, equipment and process improvements.
  • Measure the Tech services team’s performance against Key Performance Indicators; creates plans to improve the quality and efficiency of the validation team through continuous improvement.
  • Ensure compliance to cGMP at all times.
  • Ensure safety and compliance standards are maintained to the highest standards.
  • Maintain quality metrics (e.g. deviation/CAPA/QE closure, CR closure)
  • Maintain internal/external audit ready standards.
  • Maintain training compliance
  • Ensure financial compliance in line with business & financial guidance.
  • Support a culture of personal responsibility within reporting structure.

 
Skills/Knowledge Required:  

  • Leader with excellent manufacturing experience and knowledge across multiple platforms.
  • Direct experience of (including leadership) of product technical transfer.

Experience Required:

  • At least 8 - 10+ years relevant experience in pharmaceutical manufacturing environment (manufacturing operations, engineering, supply chain, quality, etc). At least 5 years relevant management experience in biopharma manufacturing. Must have experience working in a sterile manufacturing environment. Ophthalmic manufacturing experience a plus.
  • Facility construction and start up experience desired.
  • Demonstrated ability to build a high-performing team.
  • Proven track record in sterile manufacturing and support operations including qualification, start-up & early commercialisation

SALARY & BENEFITS

Negotiable - depending on experience

 

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