Within your chosen role you will be acting as part of a large team of engineers 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 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 aim to leveraging testing from Commissioning and Qualification 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 / project Validation Master Plan.
* Coordination of and participation in 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.
* Willingness and ability to support morning / evening shift work during critical periods within the project life-cycle (Cycle Development and PQ).
* 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 tasks 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:
o Leading by example in achieving results by using industry standard tools and processes
o Facilitate problem solving & risk assessment (FMEA) projects/meeting.
o Make problems visible and strive for continuous improvement.
o Serving as a team member during internal audits and to support external inspections/audits.
o 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.
Please click to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.
To find out more about Real please visit
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC(phone number removed) England and Wales