LSC have a great contract opportunity for a HVAC Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 3+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
Job Title: HVAC Engineer
Overview:
The facility is a brownfield expansion which delivers sterile drug product to patients. The facility includes formulation areas, component preparation, syringe and vial filling lines as well as visual inspection equipment.
Duties & Responsibilities:
- Development and execution of CQV testing documentation for HVAC & Clean Rooms for the Sterile Drug product facility.
- Responsible for meeting key project deliverables for safety, CQV schedule management and quality of project related documentation/electronic records for HVAC & Clean Rooms assigned.
- Responsible for ensuring GMP Clean Rooms, Cold Rooms and HVAC Equipment systems are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
- Risk Management - Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.
- Coordination with vendors & contractors during execution of Commissioning & Qualification documents.
Preferred Education and Experience:
- Bachelor's degree in a scientific, technical or engineering discipline
- 3-5 years of C&Q experience to include both documentation preparation and execution.
- Experience in CQV of Drug Substance/Drug product sterile manufacturing HVAC & Clean Rooms with integrated automation platforms.
- Experience using a digital validation execution system (e.g. Kneat or Valgenesis) is an advantage but not essential.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Stephen Abdullah on 021 4777329 if you have any more questions about this role!
