Process Equipment Engineer

3 weeks ago


Sligo, Sligo, Ireland Orion Group Full time

Orion Group Life Sciences are currently recruiting a Process Equipment Engineer on behalf of our Multinational Biopharmaceutical Client based in Sligo on an initial 12-Month contract.

Responsibilities:

  • To work as a team member to 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 a 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 vendor to ensure that equipment/facility designs are aligned and to ensure efficient transfer of information between vendor and site.
  • Review vendor design documentation to ensure compliance with process and technical specifications.
  • Lead the FAT and SAT activities ensuring the equipment is design, fabricated and tested to meet the technical requirements of the project.
  • Support foller equipment installation integration and co-ordinate vendor supervision as required.
  • Support the development of the project commissioning and validation plan.
  • Develop commissioning plans for all process related equipment ensuring that plans meet the requirements of Good Engineering Practice (GEP)
  • Review all process related validation protocols for completeness and accuracy.
  • Execute protocols in a timely basis to meet the project schedule requirements.
  • Participating in design and process project conversations to ensure reliability by design is built in prior to equipment arrival.
  • Leadership of manufacturing and validation activities during project life cycle.
  • Support of technical transfers for future product introductions to the site.
  • Assesses and owns the relationship between process requirements and unit operation equipment.
  • Understands the impact of equipment control systems on processing performance Investigate process exceptions or equipment malfunction incidents affecting the process.
  • Liaising with operations, quality and S&T to ensure equipment and process performance is maximized.
  • To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining trouble shooting and installing/commissioning equipment.
  • Implementation of equipment/process upgrade in an environment of continuous improvement.
  • Support the Production Team in ensuring that manufacturing equipment is maintained to meet the output and yield requirements.
  • Adhering to all relevant policies relating to Quality & Safety.
  • Ensure successful external inspections, and Division and Corporate audits.
  • Supervision of external contractors.

Requirements:

  • A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
  • At least six (5) years of total combined experience in Process / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.
  • At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
  • Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, and sterilization operations preferable.
  • Experience in new product introductions (drug product) to pharmaceutical facilities is desirable.
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