Company Overview:

Proclinical is seeking a Senior Validation Specialist to join a global Biopharmaceutical leader renowned for its innovation and commitment to delivering medicines to treat health conditions and improve quality of life.

Role Overview:

Reporting to the Quality Control Site Lead, the Senior Validation Specialist is a SME in testing methodology, able to troubleshoot technical issues, develop current and existing methods and be current with the latest analytical testing technologies and be able to lead and co-ordinate cross site activities for method improvements as required.

Start Date: ASAP

Duration: 12 months with possible extension

Capacity: All on-site, some flex to WFH to write reports

Hours: Mon-Fri standard

Team Size: 8-10 in Analytical Sciences and Technology department

Responsibilities:

• The team are implementing a new test – looking for someone with microbiology and method validation background.
• May do work in other other areas eg sterility.
• Lead trouble shooting investigations technical challenges with QC test method to deliver solutions for implementation through the quality system. (CAPA, Change Control)
• Provide guidance and SME oversite for execution of method standardisation and robustness program.
• Development of current and new test methods. Engaged with the latest testing technologies.
• Responsible for experimental design on key projects that involve new technologies and processes to QC.
• Responsibilities in the project management of AST studies.
• The employee is required to review data generated from validation activities and bring to the attention of Management any detrimental trend or deviation identified.
• The employee will plan their own work and the activities of others during the execution of method validation/development and transfer studies. Influence QC leadership on direction for method improvements/replacement.
• Maintains industry knowledge and awareness of new methods, equipment and techniques.
• Development of new methods. Able to identify improvements which have a positive impact to the business.

Requirements:

• University degree in a relevant scientific discipline Microbiology or similar
• Micro background and method development background
• 2-5 yrs experience in a similar role

Benefits:

• Be part of a small, dynamic team within a larger supportive environment.
• Lead scientific development studies for tech transfers, method validation and development.
• Work in a role that directly impacts the quality and safety of our products.

How to Apply:

To apply for this opportunity, please click on the APPLY NOW button and attach your up to date resume and optional: cover sheet.

For a confidential discussion, call Pamela on 02 9054 7411 or email p.phoumavong@proclinical.com

About Proclinical:

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.