Project Process Engineer

Recruiter
Location
Carlow, Ireland
Salary
Competitive Salary
Posted
20 Dec 2017
Closes
21 Jan 2018
Ref
DU17138
Contract Type
Permanent
Hours
Full Time

We are currently looking for an experienced Project Process Engineer to work with our Client’s Technical Engineering Projects group to deliver some of the ramp up projects currently planned for their site.  This is a contract role based in Carlow.

The successful candidate will execute/manage Technical Engineering projects needed to support the Client’s business.  This includes but is not limited to Process improvements, capital projects and Lean projects across multi-disciplined functions.  

Responsibilities:

  • Manage projects from scope development, design, build/install and qualify through to handover to operations 
  • Develop project scope, cost and delivery time schedule for all Tech Engineering projects, working and collaborating closely with cross functional teams as we ramp up to a fully commercial site
  • Assist 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
  • Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into required projects
  • 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
  • Required to comply with Company 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
  • Work collaboratively to drive a safe and compliant culture on site
  • Collaborate with multiple partners (e.g. Company network groups, third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programmes 

Experience Required:

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
  • Green Belt preferable
  • Considerable experience in a comparable role
  • Experience operating as a senior professional
  • 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 projects
  • Experience in leading through change would be an advantage
  • 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
  • Automation and MES knowledge
  • Proficiency in Microsoft Office and job related computer applications required
  • Lean Six Sigma Methodology experience desired

All CV’s are treated in the strictest confidence

RECRUITMENT AGENCIES NEED NOT APPLY