Senior Project Engineer

  • Contract
  • Carlow

Website Ref: TPM03152

Summary:
A global biologics company based in the midlands is looking for a Project Engineer who will lead and manage multiple Technical Engineering projects from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects.

Responsibilities:

  • Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects.
  • Develop project scope, cost and delivery time schedule for projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or Technical transfers.
  • Collaborate closely with cross functional teams to establish scope in improvement projects as the site ramps up to a fully commercial site.
  • Be accountable for equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. And requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation.
  • Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
  • Act as a liaison with global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business.
  • Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Presentations and reporting out on progress of projects to stakeholder as required.
  • Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities.
  • May be required to perform other duties as assigned.

Qualifications & Experience:

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.
  • Green Belt preferable.
  • Prior related work project engineering experience; ideally in manufacturing, preferably GMP setting with process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects but we will consider applicants from other working environments.
  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business.
  • Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects.
  • Knowledge of regulatory/code requirements to Irish, European and International.
  • Codes, Standards and Practices.
  • In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing
  • Experience of executing and/or managing through equipment and process design and validation in a sterile environment.
  • Good shipping/Filter/Cleaning validation knowledge required.
  • Knowledge of QbD/CPV desirable.
  • Excellent report, standards, policy writing skills required.
  • Automation and MES knowledge.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • Experience in audit preparation and execution desired.
  • Have a proven record of project management of change in a commercial site.
  • Proven record in planning and basic project management of a team to deliver on time/schedule and cost.
  • Proven contractor and vendor management.
  • Strong influence skills.
  • Have shown the ability to effectively manage complex projects across multiple disciplines.
  • Demonstrate analytical and systematic problem-solving skills.

To apply for this job email your details to orla.daly@tandempm.ie.