Benefits

• Work within a global team
• Monday to Friday role
• Must have unrestricted work rights

About the company
Work within a large global Biotechnology company that boasts a good company culture that is always expanding.

About the opportunity
The Validation Specialist will provide back-fill support for internal staff and contribute directly to the project as required. You will play a key role in ensuring validation activities are executed to the highest standards, in alignment with the company’s quality systems and regulatory expectations.

Duties

• Qualification of gloveless, robotic filling isolators
• Temperature mapping of controlled temperature chambers and autoclaves
• Decontamination validation of isolators
• Validation of container closure integrity testers
• Airflow visualisation studies
• Particle monitoring and HVAC re-qualification

• Execute and report periodic re-validations of GMP equipment and facilities
• Execute validation activities in support of the SA25 Filling Line Remediation Project
• Prepare and complete protocols and reports for:
• Collaborate effectively within cross-functional project teams to meet tight timelines
• Prepare and update GMP standard operating procedures and templates
• Manage validation workload and priorities in a dynamic project environment

Skills and Experience

• Degree in Engineering or Science degree in relevant discipline
• Minimum 5 years of hands-on validation experience in a GMP-regulated environment
• Prior experience with QMS, and electronic documentation management system (Veeva)
• Strong technical writing skills and attention to detail
• Proven ability to work independently and as part of a team
• Excellent organisational and time management skills

Culture
Although a large, global company, they are able to provide a family-like culture and pride itself in improving the lives of others.

Why this opportunity is right for you
This is a Full-time 12-month opportunity based in Melbourne. The position requires you to be on site Monday to Friday.

How to Apply
Click apply or contact Maddy Dwyer, Senior Recruitment Consultant on 03 9938 7101 for a confidential discussion.

About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.
Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;

• Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
• Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
• Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

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