Description
Are you a Utilities CQV Engineer interested in working for one of Dublin leading names in High-Tech Pharmaceutical Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!
Title: Utilities CQV Engineer
Rate: Negotiable
Location: Dublin, Ireland
Positions Available: 1 Engineer
Type: Contract (5 Months Rolling)
A Fantastic new role has just opened up at one of our leading Irish based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
The proposed start date is ASAP - We need YOU
Responsibilities include:
- Participate in a CQV Team with key emphasis on:
- Membership of Combined CQV Team (Vendor, Craft Contractor, Operations and CQV Personnel)
- Planning of Own Activities
- Ownership and Closure of open issues (Punch Items, Non-Conformances etc)
- Start up and commissioning of HVAC systems in a Biological and/or Pharma Environment with Siemens automation
- Qualify rooms/areas with different HVAC classifications and requirements and be responsible for same.
- Experience in System Startup, Commissioning, Functional Testing & Qualification necessary, including safe systems of work
- Takes part in troubleshooting and remediation project teams.
- Field Walkdowns of systems as part of transfer of ownership of the system from Construction
- Generation of qualification documentation
- Accountable for ensuring activities are scheduled, tracked and reported appropriately, and achieving project deadlines
- Planning and execution of all commissioning activities in adherence to site safety procedures.
- Operate in a manner consistent with the site incident and injury free philosophy.
- Understanding and applying industry specific compliance standards/regulations to all CQV activities.
- Leading Risk assessments, root cause analysis and investigations.
- Generation and review of protocols, reports, project change controls and deviations.
- Proactively highlighting any issues around compliance.
- Participates in internal and external audits and inspections where required.
- Willingly accepting challenging assignments
- Proactively keeping up to date with current thinking and best practice
Requirements:
- Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
- Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (min 2 - 5 years)
- Relevant experience as subject matter expert/engineer in a high tech industry such as Biotech or Pharma, preferable. Experience working on and knowledge of HVAC systems and cleanrooms, including start up.
- Experience in using Siemens automation platform and review/approval of associated documentation essential.
- Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
- Experience in quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage.
- Experience in IMB/FDA environment advantageous.
- Relevant experience as subject matter expert/engineer in a high tech industry such as Biotech or Pharma, preferable. Experience working on and knowledge of Biopharma unit operations, including start up.
- Excellent technical abilities with a solid base in engineering.
- Strong technical writing and communication skills.
- Proven track record in generation of validation/verification documentation.
- Must be goal-oriented and able to prioritize and manage tasks.
If you are interested please do not hesitate to email or call me!
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