Hamlyn Williams have partnered with one of the Global Life Sciences (Engineering) Consultancy firm that also work with major Pharmaceutical and Biotechnology companies, helping them to maintain their GxP organisations. Due to exponential growth from this Global Life Science Consultancy firm, they have been able to demonstrate from previous projects to the end client that they have had a huge impact on starting and scaling up the GxP projects which they have done successfully. The end clients are also a rapidly expanding Biotech CDMO facility and due to their expansion they are now building a new manufacturing facility across their main campus. With this new facility, the Consultancy firm are currently in search of a Senior Validation Engineer that will be hired on a permanent basis that will not only work this certain project but will also have the chance to collaborate with other professionals in the Validation division on further exciting and innovative projects. The scope of the work will involve the commissioning, qualification and validation (CQV) for both Equipment and Utilities. As this is a Senior position, you will also be involved in the oversight, mentoring and coaching of junior candidates.
They’re aware that the market value is going up, therefore are offering flexibility and a very generous, lucrative, overall compensation package.
As the Senior Validation Engineer you will be involved in:
- Acting as the Validation Lead for IOQ and PQ development - responsible for the execution of existing and new equipment, utilities and facilities.
- Responsible for the Life Cycle Documentation (FAT, SAT, CTP, DQ, IOQ, PQ) for facilities, utilities, manufacturing/QC lab equipment (cell culture, protein purification, cell and gene therapy, fill-finish)
- Collaborate with cross-functional team to ensure Validation projects are executed in a timely manner
- Provide technical support towards manufacturing activities - Deviation, Root Cause, Change and Optimization
As the Senior Validation Engineer you will require:
- 5 - 7 years of Validation experience within Pharmaceutical or Biotechnology industry
- Commissioning, Qualification, Validation (CQV) experience
- Equipment Validation - Bioreactors, Autoclaves, buffer tanks, incubators etc.
- Facilities Validation - HVAC, Clean Room etc.
- Utilities Validation - Water Systems, Clean Steam, WIFI etc.
- Full Project Life Cycle experience - DQ, IOQ and PQ
- Experience with writing Validation protocols, executing Validation and reviewing and approval of documentation
PLEASE NOTE: The client can offer visa sponsorship.
Please get in touch with me for more details by applying and sending across your resume if this role is of interest.
Contact: +1 646-849-4261 or email firstname.lastname@example.org
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