Senior Manufacturing Process Specialist

Orion Group Life Sciences are currently recruiting a Senior Manufacturing Process Specialist on behalf of our Multinational Biopharmaceutical Client based in Cork on an initial 12-Month contract with huge potential to extend.
 
Role Overview
The Manufacturing Process Specialist is a core member of the Business Unit, responsible for providing technical support to ensure efficient manufacturing operations while maintaining full compliance with GMP and EHS standards at all times.
 
Experience & Background Requirements

• Minimum 5 years’ experience in a manufacturing operations or similar role.
• Industry experience: Aseptic / Sterile manufacturing, API (Active Pharmaceutical Ingredient) manufacturing or Biologics / Biopharma manufacturing

 
Key Skills & Attributes

• Strong communication skills
• Excellent organisational skills
• Proven ability to adhere to deadlines
• LEAN experience (advantageous)

 
Responsibilities:
Technical & Operational Support

• Develop new and revised manufacturing and cleaning recipes in line with Master Batch Book requirements.
• Develop and report on performance metrics across the business unit, including preparation of scorecards, dashboards, and management review data.
• Attend operations meetings as required to support the Business Unit.

 
Investigations & Compliance

• Lead and manage investigations including:
  • Customer complaints
  • EHS incidents
  • Non-Conformances (NCPs)
• Conduct root cause analysis and implement corrective and preventive actions (CAPA).
• Manage manufacturing-related aspects of the Change Control system in line with site procedures.
• Ensure full compliance with GMP and EHS standards.

 
Process Improvement & Risk Management

• Participate in HAZOP studies to identify and eliminate potential process risks.
• Identify opportunities for continuous improvement through:
  • Trend analysis
  • Self-inspections
  • Internal audits
  • Process optimisation
• Partner with business unit personnel to proactively develop innovative solutions.
• Develop reprocessing/rework strategies, test methods, and protocols.

 
Competencies
The competency to perform this role is acquired through appropriate qualifications, education, training, and experience (knowledge & skills), or a combination thereof.
 
Minimum Requirements

• Third-level qualification in a relevant scientific, engineering, or technical discipline.

 


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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.