An amazing opportunity has arisen for a Validation Engineer on a contract basis with Crest Solutions based on client site.

WHAT WE DO

Crest Solutions are an Engineering & Software company that supply and support the resourcing of engineers, analysts, specialists and other professionals in this field. We are home to a vibrant group of professionals, working together to deliver to our clients. As a Gold Certificated company in the NSAI Excellence Through People scheme, Crest Solutions strives to guide many of Ireland’s most successful organisations to become more efficient, productive, flexible, competitive and innovative, through the development of great people.

THE EXPECTATIONS

Within your chosen role you will be acting as a senior engineer reporting within the Technical Engineering department, the role will include -

• 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.

• This role requires 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.

• S/he will also have 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.

• 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.

• The candidate will also show ambition and drive to develop and advance within the role.