Commissioning, Qualification and Validation Engineer
Reference: SMC72956
Location: Carlow
Qualification: Degree
Experience: See description
Job Type: Fixed Term Contract
Salary: Not Disclosed
Duties
* Executing with a view to leveraging testing from Commissioning and Qualification to PQ where possible.
* Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
* Implementing the requirements as outlined in the site / C&Q and project Validation Master Plan.
* Coordination of engineering sub-teams in the assigned suite during execution of IQ/OQ / Cycle Development & Validation activities.
* Authoring and reviewing standard operating procedures and technical reports including IOC/ IOQ & PQ protocols.
* Technical owner of Commissioning protocols, Qualification protocols and input to Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
* Supporting regulatory submissions as required.
* Input to Change Management process for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.
* Effective application of LeanSixSigma and Change Management tools in the Validation group by:
* Leading by example in achieving results by using industry standard tools and processes.
* Facilitating problem solving & risk assessment (FMEA) projects/meeting.
* Making problems visible and striving for continuous improvement.
* Serving as a key member during internal audits and external inspections/audits.
* Supporting various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).
* Keeping up to date with scientific and technical developments, best practices and attending seminars as required.
* Maintaining continuous focus on quality and safety compliance and unflinching focus on the customer.
Education & Experience
* Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects.
* SME on Equipment Validation on any of; Parts Washer / Autoclaves / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities - Transfer Panels & Formulation / Visual Inspection/ Single Use Technologies.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information. #J-18808-Ljbffr