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Technical Recruiter at NIRAS Ireland - NRF CERT RP
NIRAS Ireland is currently recruiting a Biologics Process Equipment Engineer to join our client's team based in Sligo. The successful candidate will participate in process, equipment, and facilities validations efforts and projects implementations. This is a 12 month contract role based 100% onsite.
Responsibilities:
• Develop and modify procedures as needed to support the manufacturing operation.
• 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 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)
• 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.
• 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 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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
Referrals increase your chances of interviewing at NIRAS Ireland by 2x
Equipment & Facility CQV Engineer- Pharma/BioPharma
County Sligo, Ireland €50 - €60 2 weeks ago
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