EQUIPMENT QUALIFICATION SITE LEAD required by CareerWise REcruitment for our client to support their new Biologics Manufacturing Facility.
The EQUIPMENT QUALIFICATION SITE LEAD is responsible for all aspects of qualification and operations of all temperature controlled units (TCUs) and supporting HVAC system, as required. They will develop the start-up strategies, influence the organisation structure and transition into supporting execution of control strategies in the manufacturing facility, post start up.
Role of this position
- User rep for design and operation of all temperature-controlled units (TCUs) in the Limerick site.
- Design control strategy including alarm rationalisation, monitoring and response for all temperature-controlled storage areas.
- Interact with Development to influence early molecule storage considerations for manufacturing.
- Support Mapping Studies to ensure temperature mapping is integrated into control strategy for required product interactions movement e.g. shipping, unloading and loading freezers
- Define the business processes for temperature-controlled unit interactions including work instructions, procedures etc
- Support FMEAs, safety risk assessments, Job Hazard Assessments on introduction of walk-in freezers / cold rooms
- Work with business partners, procurement and vendors to build robust SLAs and develop preventative maintenance programme for onsite TCU's
- Design & influence paperless system for product movements to ensure all moves are executed according to while maintaining paperless approach.
- In conjunction with Automation/IT Team, support the design of interactive user dashboards to monitor and trend alarms / performance.
- Design and own BCP for temperature control units, site wide.
- Influence the overall design of the Organisation, taking into account cross functional interactions.
- Work with team of HVAC Engineers to support HVAC Systems, where required
- Post start up activities will include:
- Custodian for Temperature Controlled Storage areas across Limerick site
- Execution of alarm strategy including ongoing monitoring and alarm response for both TCUs
- Support deviation & change management, where applicable.
- Provide front line inspection support for TCU qualification, control strategy and alarm parameters and qualification
- Provide support to HVAC Systems team, where required.
- BSc/MSc Engineering or related discipline with a minimum of 5 years pharmaceutical experience.
Please call Conor Twomey today for further information on 087-0907204 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)