CK Group is recruiting for a Validation Engineer to join a company in the Pharmaceutical industry at their site based in Carlow on a contract basis for 11 months and has a daily/hourly rate of €61.88 LTD
Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. This position sits within their Manufacturing Division, which consists of a team of dedicated, energetic individuals, committed to being the most trusted supplier of pharmaceuticals and health products worldwide. They have an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The role is based at our client's site in Carlow, Ireland. Carlow is a fascinating town which pre dates written Irish history, has played a major part in Irish history and even served as the capital of the country in the 14th century. Carlow is located approximately 50 miles from Dublin and has good rail links as well as being close to the N9 & N80 roads.
Within your chosen role you will be acting as a senior engineer reporting within the Technical• 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.
- 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.
- 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.
- Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects
- Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines
- Experience with sterile processing and sterilisation technologies
- SIP and CIP subject matter extensive experience
- Autoclave Qualification and Sterilisation Loads Cycle Development experience
- Warehouse and CTU qualification
For more information or to apply for this position, please contact Lucy on 01246 457725 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47095 in all correspondence.