Sterile New Product Program Engineer

A Sterile New Product Program Engineer is required by CareerWise Recruitment for our County Galway based client. As Sterile New Product Program Engineer, you will support the delivery of 3-year Commercialization Program for a new filling product line. Reporting directly to the Strategic Development & Commercialization Lead, this role is responsible for executing engineering activities required to prepare facilities, utilities, and equipment for a new aseptic filling process. You will ensure systems and processes are designed, installed, qualified, and validated in compliance with GMP and regulatory requirements, enabling successful process validation and commercial launch. #3-YEAR CONTRACT POSITION

THE ROLE:

• Support facility modifications and readiness activities for aseptic processing areas
• Participate in gap assessments against process and product requirements
• Assist in implementing facility upgrades such as RABS/ORABS systems
• Support qualification and monitoring of critical utilities (WFI, clean steam, gases, HVAC)
• Execute utility risk assessments and assist in requalification activities
• Execute commissioning and qualification activities (IQ/OQ/PQ)
• Support validation of aseptic systems including media fills
• Assist in CIP/SIP validation and calibration planning
• Develop and review URS, FAT/SAT, and validation protocols & Participate in FAT and SAT activities
• Support deviation and change control processes
• Update all appropriate site drawings and documentation to support the product launch
• Develop SOP’s for the new equipment and processes
• Train operators on the new equipment and processes
• Collaborate on process characterization and validation activities
• Support PPQ batch execution and Exhibit batches in manufacturing
• Support validation of automated systems (PLC/SCADA)
• Assist MES integration and electronic batch records
• Work closely with other functions & Support training of operations and maintenance personnel

REQUIREMENTS:

• Bachelor's Degree in Engineering (Mechanical, Chemical, Process, or related field)
• Project Management Professional(PMP) or equivalent a distinct advantage
• Knowledge of Lean Six Sigma
• 3 - 7 years in Pharmaceutical or Biopharmaceutical manufacturing, with experience in Sterile/Aseptic environments preferred
• Knowledge of GMP and regulatory standards (Annex 1, FDA)
• Hands-on experience in equipment qualification and validation
• Understanding of cleanroom operations and contamination control
• Familiarity with CQV lifecycle and utilities systems
• Working knowledge of automation systems and data integrity
• Strong problem-solving and analytical skills
• Ability to manage multiple tasks
• Effective communication and teamwork
• High attention to detail and compliance focus

Please call Tom Devaney for further information on 091-758771 or email: tdevaney@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri Sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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