14496 – Validation Engineer – Carlow Contractor

This is an 11 month contract with our client in Carlow . Strong rates are available.

There are 4 broad technical areas that will require the leadership of experienced, energetic, and committed engineers –
• Sterilisation – Autoclaves, SIP of vessels
• Cleaning – Parts Washer and CIP of vessels
• Vial and Syringe filling operations –Glass handling, Tray & Tub handling, Drug Product Filling, and Parenteral Product Visual Inspection.
• Vial and Syringe Sterility operations – Isolators, VHP, E-Beam, and Depyrogenation systems.
The successful candidate will need to have demonstrated experience in one or more of these areas.

Responsibilities:

• Engage in the early stages of the project, giving input into the design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests. Oversee equipment C&Q within the assigned area with a view to ensuring right-first-time C&Q and Validation effort.
• Act as validation SME on the equipment within the area assigned. As such you will be leveraging testing from Commissioning and Qualification.
• 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/project Validation Master Plan.
• Coordination of engineering sub-teams in the assigned suite during the execution of Cycle Development & Validation activities.
• Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
• Technical review and approval of Commissioning protocols, Qualification protocols, and Validation protocols executed by vendors, cross-functional groups, and/ or validation counterparts.
• Supporting regulatory submissions as required.
• Owning 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
• Facilitate problem-solving & risk assessment (FMEA) projects/meetings.
• Make problems visible and strive for continuous improvement.
• Serving as a key member during internal audits and external inspections/audits.
• Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
• Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).
• Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
• Keep up to date with scientific and technical developments, best practices and attend seminars as required.
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
• Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.

Minimum Qualifications and Experience: 

• Engage in the early stages of the project, giving input into the design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests. Oversee equipment C&Q within the assigned area with a view to ensuring right-first-time C&Q and Validation effort.
• Act as validation SME on the equipment within the area assigned. As such you will be leveraging testing from Commissioning and Qualification.
• 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/project Validation Master Plan.
• Coordination of engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.
• Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
• Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
• Supporting regulatory submissions as required.
• Owning 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
• Facilitate problem solving & risk assessment (FMEA) projects/meeting.
• Make problems visible and strive for continuous improvement.
• Serving as a key member during internal audits and external inspections/audits.
• Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
• Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).
• Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
• Keep up to date with scientific and technical developments, best practices and attend seminars as required.
• Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.