Arcadis DPS are seeking a Filling Line Projects Engineer on an hourly rate contract basis for a leading Biopharma company in Sligo
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
Interested parties should apply via the link below or contact Fergal Walshe via LinkedIn for more information
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