9934 – Validation Engineer – Carlow Contractor

Purpose:

An exciting opportunity has come to join the Commercialisation team to transition from a project phase to a fully operational facility delivering life-saving products to patients. There are 4 broad technical areas that will require the leadership of experienced, energetic and committed engineers – (1) Sterilisation – Autoclaves, SIP of vessels (2) Cleaning – Parts Washer and CIP of vessels (3) Vial and Syringe filling operations –Glass handling, Tray & Tub handling, Drug Product Filling and Parenteral Product Visual Inspection. (4) 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:

• Responsible for introducing new processes and/or products (product transfer.)
• Develop and transfer knowledge of Lean Six Sigma, Change Management and Inclusion.
• Steer and/or participate in cross-functional investigations on problems/deviations – including defining corrective and preventive actions.
• Identify, analyze and prioritize technical or business related processes improvement-opportunities and problems.
• Initiate and coordinate improvements for technical or business processes, systems and behaviors.
• Contribute to a data driven decision making process, Ensure effective application of LeanSixSigma and Change Management tools by leading projects, facilitating kaizens and coaching sponsors and practitioners.
• Works with moderate work direction and is skilled and knowledgeable to the position.
• Engage in the early stages of the project, giving input into 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.
• 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:

• With relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
• An experienced individual with a minimum of 5 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.
• The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours.
• Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
• The candidate will also show ambition and drive to develop and advance within the role.