Job Title: Senior Validation Specialist
We are currently recruiting for a highly skilled and experienced validation specialist to join our team.
This is an excellent opportunity for individuals who have a strong background in cleaning validation, with a proven track record of delivering excellence in a GMP manufacturing setting.
About the Role
The successful candidate will be responsible for designing, authoring, reviewing, approving, and executing qualification/validation documentation and cycle development studies in line with the standard approval process.
They will also design, author, review, approve, and execute execution/development of change controls, as well as resolving technical issues encountered during study execution.
Key Responsibilities:
* Design/author/review/approve/execute qualification/validation documentation and cycle development studies in line with the standard approval process.
* Design/author/review/approve/execute execution/development of change controls.
* Resolving technical issues encountered during study execution.
* Engagement with Production, Maintenance, and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
* Technical input into quality notification by authoring/reviewing/approving investigations.
* Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
* Support continuous improvement through Lean Six Sigma methodologies.
* Serve as validation representative for cross-functional projects and represent the validation team at global technical forums.
* Drive compliance of Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
* Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactively highlighting any issues around compliance.
* Supporting regulatory audits and submissions as required.
Required Skills and Qualifications
The ideal candidate will have:
* Experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP) including recipe development & optimization, cleaning verification, cleanability, and recovery studies using TOC, ICP, & swab methods, acceptable residual limit determination, worst-case soil matrices & strategy development.
* Considerable experience in a comparable role, with experience operating as an individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
* Exception/Deviation Management and Change Control.
* Demonstratable experience of leading technical-related projects.
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
* Equipment and process validation.
* Sterile Fill-Finish processes and equipment.
Benefits
This role offers a unique opportunity to work in a dynamic and fast-paced environment, with a focus on delivering excellence in cleaning validation.
The successful candidate will have the opportunity to develop their skills and knowledge in a variety of areas, including process validation, equipment validation, and cleaning verification.
In addition, the role offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
Others
Please note that this is a hybrid role, working between office and home environments. The successful candidate will need to have the ability to work independently and as part of a team, with excellent communication and interpersonal skills.
If you are interested in this opportunity, please submit your application, including your resume and cover letter, to [contact information]. We look forward to hearing from you.