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Equipment Life Cycle Specialist

GMP automation CSV laboratory

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for an Equipment Life Cycle Specialist.

Keywords
  • B.Sc./M.Sc.
  • 4 years experience in Pharma wih GMP and automation
  • Lab experience
  • Software
  • CSV

We are looking for an Equipment Life Cycle Specialist who has demonstrable experience and affinity with implementing equipment in a GMP environment. Furthermore, you need to be able to manage multiple issues, organise activities, prioritise, and maintain a clear line of communication within multidisciplinary teams.
Data integrity, setting up and maintaining computerised systems as well as robotics are examples of Automation activities in support of well-functioning laboratories. You will also contribute to maintaining cGMP compliance and support the LEAN status of the team.

Tasks and responsibilities:
  • Responsible for the implementation of new systems within the organisation in collaboration with other teams. Lab systems vary from (standalone) analytical equipment to complex global platform projects which connect to LIMS (Laboratory Information Management Systems);
  • Responsible for documenting administrator procedures, technical installation procedures and maintenance procedures;
  • Implementation of equipment within the agreed timelines;
  • Take part in Lab Systems initiatives and projects, in co-operation with the global organisation and in alignment with business needs;
  • Informing lab managers / supervisors of required corrective actions after publication of new and/or modified regulations to ensure compliance status of existing and new systems (USP, GAMP, GMP, ERES);
  • Involved in maintaining the equipment validation master plan for QC equipment (inventory, qualification status, additional information as required);
  • Engage with equipment vendors to understand and implement new versions of technology in service of improving reliability and performance;
  • Monitoring of projects & Managed service providers spend to stay within planned budget;
  • Oversee communication between internal and external parties during the analytical equipment implementation process.

Profile

The ideal candidate has a B.Sc. or M.Sc. degree in Life Sciences with at least 4 years of experience in Pharma with GMP and automation. Hands on experience in a lab is required.
We are looking for someone with (some) experience with (Computer) System Validation in a GxP environment. Experience with the following software is advantageous: Empower, Softmax pro, SDMS, Deskman, LIMS, 32Karat, Trackwise, Compliancewire.
Are you able to prioritise multiple commitments, are you pro-active, communicative and do you know how to write protocols/reports, business correspondence and procedures? Then we are looking for you!

Benefits

Salary: >3150
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Project for at least 1 year
32-40 hours
5 days per week onsite would be desirable

Company profile

Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.
Location Leiden
Equipment Life Cycle Specialist

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