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Commercial Manufacturing Technician

1 week ago

Dublin, Dublin City, Ireland PSC Biotech Corporation Full time

About PSC Biotech Corporation

PSC Biotech Corporation is a renowned provider of cloud-based software solutions for Quality Management and Regulatory Inspections, serving pharmaceuticals contract manufacturing professionals and metrology services to clients worldwide.

We have a strong global presence, with operations in Ireland, India, Singapore, Australia, and the US, serving over 350 clients in more than 23 countries. Our company culture fosters innovation, collaboration, and customer satisfaction.

Job Role:

The Bioprocess Associate will be responsible for managing commercial large-scale drug substance production at our manufacturing facility. This includes preparing, operating, and monitoring equipment, using business systems, and performing tasks such as cleaning, validation, in-process testing, and basic maintenance according to cGMPs.

Key Responsibilities:

  • Collaborate with the manufacturing operations group, project design team, the CQV team, and the Automation/CSV reps to develop and validate the manufacturing facility.
  • Support Equipment Design/HAZOP and Room programming reviews.
  • Assist the Operations team to meet specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance, and team training.
  • Implement commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
  • Generate SOPs/Electronic Batch Records.
  • Adhere to Right First-Time principles.
  • Collaborate with maintenance, engineering, quality, or other colleagues as requested.
  • Liaise with other groups and individuals to ensure task planning is effective and linked into the manufacturing process plan.

Requirements:

  1. A level 6 with a minimum of 3 years' experience in a GMP Manufacturing requirement shall be deemed equivalent.
  2. Minimum of a Level 7 qualification in a science or engineering discipline.
  3. Excellent communication and teamwork skills.