Manufacturing Process Specialist

2 weeks ago

Sligo, Sligo, Ireland beBeeProjectEngineer Full time €80,000 - €100,000

Job Overview

Arcadis DPS is seeking a Filling Line Projects Engineer on an hourly rate contract basis for a leading Biopharma company.

Main Responsibilities:

  • Support engineering in pharma operations in line with all safety, regulatory and organizational requirements.
  • Develop and modify procedures as needed to support the manufacturing operation.
  • Participate in process, equipment, and facilities validations efforts and projects implementations.
  • Process and equipment engineering Subject Matter Expert for vial filling and isolator equipment from design phase to equipment handover.
  • Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID's.
  • Interface with vendors to ensure that equipment/facility designs are aligned and efficient transfer of information between vendor and site.
  • Review vendor design documentation to ensure compliance with process and technical specifications.
  • Lead FAT and SAT activities ensuring equipment meets technical requirements.
  • Support follow-up equipment installation integration and coordinate vendor supervision.
  • Support development of project commissioning and validation plan.
  • Develop commissioning plans for process-related equipment ensuring plans meet Good Engineering Practice (GEP) requirements.
  • Review process-related validation protocols for completeness and accuracy.
  • Execute protocols in timely manner to meet project schedule requirements.
  • Participate in design and process project conversations to ensure reliability by design is built prior to equipment arrival.
  • Leadership of manufacturing and validation activities during project life cycle.
  • Support technical transfers for future product introductions to the site.
  • Assess and own relationship between process requirements and unit operation equipment.
  • Understand impact of equipment control systems on processing performance.
  • Investigate process exceptions or equipment malfunction incidents affecting the process.
  • Liaise with operations, quality and S&T to ensure equipment and process performance is maximized.
  • Liaise with internal/external engineering personnel and contract maintenance providers in maintaining trouble shooting and installing/commissioning equipment.
  • Implementation of equipment/process upgrade in continuous improvement environment.
  • Support production team in ensuring manufacturing equipment meets output and yield requirements.
  • Adhere to all relevant policies relating to Quality & Safety.
  • Ensure successful external inspections and Division and Corporate audits.
  • Supervise external contractors.

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