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Commercial Manufacturing Associate

3 weeks ago

Dublin, Dublin City, Ireland Psc Biotech Ltd Full time

PSC Biotech Ltd Overview

PSC Biotech Ltd is a renowned consultancy firm with global operations.

Our team provides cloud-based software solutions for Quality Management and Regulatory Inspections.

We serve over 350 clients worldwide and have operations in multiple countries.

As a consultancy firm, we align our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry.

Job Description:

A fantastic opportunity has arisen for a Bioprocess Associate.

This role involves preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the cleaning, validation, in-process testing and basic maintenance of equipment in accordance with current Good Manufacturing Practices (cGMPs).

Key Responsibilities:

  • Work with the manufacturing operations group, project design team, the CQV team, the Automation/CSV reps to facilitate the development and validation of the manufacturing facility.
  • Support Equipment Design/HAZOP and Room programming reviews.
  • Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance and team training.
  • Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
  • Generate SOPS/Electronic Batch Records.
  • Adhere to Right First-Time principals.
  • Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
  • Escalate issues as appropriate to Process Lead
  • Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.