Lab Equipment & Process Readiness Specialist

Lab Equipment & Process Readiness Specialist – Team Horizon
We are seeking applications for an experienced Technical Services Specialist to join our clients Bulk Drug Manufacturing facility in Dublin.
The Equipment and Process Readiness Specialist (TT/Lab start-up) will support and shape the start-up of the MSAT Labs on our client’s site.
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding focus on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.

 
What you will be doing:

• You will work on the following areas


• Generation of URS’s for process and analytical equipment


• Support ongoing queries in relation to equipment selection


• Support selection and preparation of procurement details for lab chemicals, reagents, and consumables, with the creation of bill of materials


• Perform and input to risk assessments while partnering with MSAT team


• Support CQV with the commissioning and qualification of equipment


• Interact with vendors to support queries


• Support the readiness for technology transfer of lab models and associated analytical method transfers


• Create and track metrics, dashboards, schedules, project timelines, booking and facilitating meetings


• Create and implement systems for the labs


• Generate master lists for equipment and materials


• You will work closely with team members of the MSAT Labs in the areas of cell culture, purification and analytical, project team, CQV and other functions in this new, exciting, MS&T labs start-up.


• Provide technical and user requirements in support of the design, fit out and start up of the MSAT Labs


• Support technology transfer and lab operational readiness


• Collation of data to generate metrics including project timelines


• Setup and facilitation of meetings with cross functional groups


• Generation, and maintenance of project documentation, material specifications, and SOPs/Logbooks


• You will bridge efficient communication and decision making related to the technical requirements for the project


• Engage with the business to map and plan out lab model and analytical method technology transfers, timelines and requirements

 
 
 
What you need to apply:

• A degree in Life sciences or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering/lab start up or operations with 8+ years


• Excellent communication skills with the ability to successfully influence across levels, across functions, with senior leaders and technical leaders


• Ability to work in a complex, dynamic, global environment, thinking strategically and balancing both long and short-term priorities


• The duties of this role are generally conducted in a lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry items in accordance with manual handling principles; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours