Validating Process Excellence

6 days ago

Adelaide, South Australia beBeevalidation Full time $115,000 - $157,000

About BioCina

BioCina is a biologics contract development and manufacturing organization (CDMO) specializing in process development and cGMP manufacture of microbial-based therapeutics and plasmid DNA, from preclinical to commercial production. The company has 35+ years of microbial fermentation experience and over the past 15 years, has worked on over 50 different products and has partnered with more than 30 customers globally.

We are looking for a Validation Specialist to spearhead the repositioning of our capabilities to achieve new heights for the organisation. The primary function of the role is to provide validation, cross contamination, and New Product Introduction (NPI) expertise for the site and to direct and manage validation requirements and activities.

Key Responsibilities:

- Provide advice and expertise to Validation, Production, Analytical Development and Quality teams in relation to validation requirements.
- Ensure validation procedures are in place and complied with as per current Regulatory and Corporate requirements.
- Lead the team providing technical advice and performance feedback to achieve individual, team, and site goals and objectives.
- Collaborate closely with cross-functional teams to ensure alignment and timely execution of validation plans.

Requirements:

- Bachelor's or master's in a scientific or engineering discipline.
- 7 - 10 years of working knowledge and practical experience with validation principles across equipment, process, method, cleaning, and computer system validation
- Experience working in utilities and general production systems used in the manufacture, testing, and holding of bio-pharmaceutical products.
- Strong knowledge of cGMP including ICH Q7 and international codes of GMP (FDA and EU).
- Working knowledge of the GAMP good practice guides and experience in phase appropriate manufacturing requirements.
- Exceptional attention to detail regarding documentation.
- Excellent communication skills and ability to work as part of a highly skilled Validation team.
- Experience using the Microsoft Office suite, in particular MS-Word and MS-Excel.
- Experience working in a biologics CDMO environment is essential.

Why Work with Us?
- Competitive remuneration: We offer a competitive salary and comprehensive benefits package.
- Career growth opportunities: We believe in growing our people and provide ample opportunities for career development and advancement.
- Innovation and impact: Be part of a company that goes beyond the boundaries of science and making a positive impact on patients' lives.
- State-of-the-art facility: Utilise cutting-edge technology and work in a modern, well-equipped facility that fosters creativity and productivity.
- Collaborative environment: Work alongside passionate and expert professionals who are dedicated to excellence and shared a common goal.

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