Senior Process Engineer (Hybrid)

2022-08-03 15:52:182049-12-30Team Horizon
Job TypePermanentContractor
Start Date
AdvertiserHilda Lynn
Telephone+353 98 33013
Job Ref#1002568
Job Views107
2568 - Senior Process Engineer
Team Horizon is seeking a Senior Process Engineer to work on our client site in the Waterford area. You will lead process equipment introductions & qualifications, subsequent process validations, organising operations & maintenance support, raw materials for engineering/process optimisation batches.
What you will be doing:
  • In this role you will provide process engineering support and project leadership to support internal customers in the day to day operations of the organization and site capital projects, enabling delivery of high quality projects safely, on time and within budget
  • Identify and manage process improvements and projects
  • Lead in the procurement, introduction, commissioning and qualification of process equipment and subsequent process validations
  • Ensure qualification methodology is clear and integrated into the project from URS onwards
  • Ensure documentation, training and handover meet the internal customers’ expectations
  • Consider life cycle cost in designs for maximum long term efficiency and reliability
  • Plan and execute process validation schedules for manufacturing and packaging processes.
  • Write and execute documents for the validation of new and existing processes.
  • Liaise with contractors/customers when external resources are required to complete validations.
  • Liaise with relevant departments to organise resources/materials/ equipment/facilities/etc and ensure validation activities are planned and executed in line with applicable deadlines.
  • Assist with submission/audit/deficiency responses activities when required, in a timely manner.
  • Draft/revise/review validation related documents e.g. SOPs, protocols, reports etc.
  • Generate, analyse and interpret statistical data to verify acceptable criteria has been met and support process validations, CPVs
  • Develop testing strategies and rationale for manufacturing and packaging process equipment qualification and process validation.
  • Provide technical support/troubleshooting for process and equipment issues.
  • Investigate/resolve deviations associated with validation activities.
  • Utilise structured problem solving in support of process issues & problem resolution.
  • Ensure contractors are budgeted, approved, scheduled, qualified and permitted for the work they perform under your behest
  • Report on schedule, cost control, project scope and risks / mitigations at appropriate intervals
What you need to apply:
  • If you are a Process Engineer qualified to a minimum of degree level in an Engineering discipline and have 5+ years’ experience working in a clean room, Pharma, medical device or similar manufacturing and/or packaging environment we want to hear from you.
  • Ideally you will have experience in process validation (including statistics training) and the management of small capital projects along with knowledge of the processes and equipment used in the manufacture and packaging of tablets and capsules. Knowledge of cGMP, EU Annex and GAMP requirements, an understanding of integrated validation approaches and familiarity with Minitab or similar statistics software is an advantage.
  • You have a customer focused mindset with strong attention to detail and problem solving - previous experience in leadership roles, direct or indirect would be an advantage.
  • You will draw from many skills including adaptability, planning, multi-tasking and time management.
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