Job Title: Validation Specialist x 2

Job Function: Validation

Therapy Area/Industry: Pharmaceutical/Biotechnology

Job Type: 12-Month Contract with possible extension

Pay Rate: $62.50 - $72.50 per hour + superannuation

Location: Melbourne, CBD

Hours: Mon to Fri standard, occasional overtime or weekends by exception

Capacity: All onsite but with potential occasional WFH negotiated with manager

Company Overview:

Proclinical has partnered with a globally recognized leader in biotherapeutic solutions, dedicated to saving lives and improving the quality of life for people with rare and serious medical conditions.

The Elizabeth St, Melbourne CBD site is a newly established, state of the art global headquarters and centre for research and development facility designed to be a powerful catalyst for scientific discovery in Australia boasting seven stories of world class labs and pilot scale manufacturing capabilities.

Job Description:

Proclinical is seeking 2 x dedicated Validation Specialists to support a critical project. In this role, you will be instrumental in executing validation activities to ensure compliance with quality systems and regulatory standards. Your expertise will contribute to maintaining high standards in a dynamic project environment.

Responsibilities:

Equipment validation activities, preparing validation protocols, executing protocols.

Writing reports with results to show equipment is suitable for use.

Variety of equipment – e.g. temperature chambers, isolators, integrity testers, Environmental monitoring.

Autoclave.

Writing procedures.

Conduct and report on periodic revalidations of GMP equipment and facilities.

Execute validation tasks for the filling line remediation project.

Prepare and complete protocols and reports for various validation processes, including qualification of robotic filling isolators, temperature mapping, decontamination validation, and more.

Collaborate with cross-functional teams to meet project deadlines.

Develop and update GMP standard operating procedures and templates.

Manage validation workload and prioritize tasks effectively.

Key Skills and Requirements:

Min 5 yrs experience in a similar role.

Work well in a team and meet deadlines.

Excellent skills in doc writing, technical writing.

Proficiency in validation within a GMP-regulated environment.

Familiarity with quality management systems and electronic documentation tools is advantageous.

Strong technical writing skills with keen attention to detail.

Ability to work independently and collaboratively.

Excellent organizational and time management abilities.

How to Apply:

If you are having difficulty in applying or if you have any questions, please contact Pamela at [email protected]

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.