About BioCina

BioCina is a global end-to-end Contract Development and Manufacturing Organisation (CDMO) offering clients unparalleled quality, adherence to the highest regulatory standards, and industry-leading on-time and in-full delivery, setting a new benchmark in the industry for quality and reliability. With deep expertise in small molecules, microbial, pDNA, and mRNA modalities, BioCina’s comprehensive service offerings include cell line development, process development, analytical and formulation development, and cGMP clinical and commercial manufacturing. BioCina operates two state-of-the-art facilities in Adelaide, South Australia, and Perth, Western Australia.

As one of the fastest-growing companies in the biopharmaceutical industry across Australia, BioCina was awarded the 2024 South Australia “Emerging Business of the Year” award.

The Validation Specialist is responsible for supporting process and cleaning validation activities in pharmaceutical manufacturing. This role involves ensuring that processes, equipment, and systems meet regulatory, quality, and safety standards. A focus on contamination control and adherence to Good Manufacturing Practices (GMP) is essential. Experience in quality systems and knowledge of aseptic processing are desirable.

Responsibilities:

Process & Equipment Validation:

Develop, execute, and document validation protocols (IQ, OQ, PQ) for new and existing manufacturing processes. Conduct process performance qualification (PPQ) to ensure systems operate as intended.

Cleaning Validation:

Support cleaning validation activities to ensure equipment cleanliness meets regulatory standards. Develop and implement cleaning protocols, sampling, and analysis for product changeovers.

Contamination Control:

Support the assessment of contamination control strategies, including environmental monitoring and ensuring compliance with contamination control requirements (particularly in sterile and aseptic environments). Collaborate with quality teams to mitigate risks related to contamination.Author and review validation documentation, including protocols, reports, risk assessments, and change control documentation. Maintain detailed, compliant records.Work closely with quality assurance, production, engineering, and regulatory teams to ensure all validation activities align with company and regulatory standards. Support audit readiness and participate in regulatory inspections.Identify and implement process improvements to enhance product quality, efficiency, and compliance. Stay current with industry trends and regulatory requirements related to validation and contamination control.

Documentation and Reporting:

Cross-Functional Collaboration:

Continuous Improvement:

Qualifications:

Bachelor’s degree in engineering, Chemistry, Microbiology, or related field.

3+ years of experience in pharmaceutical manufacturing or a related industry, with a focus on validation.

Strong understanding of contamination control principles, especially in aseptic/sterile manufacturing environments (desirable).

Knowledge of regulatory requirements (FDA, EMA, TGA) and quality systems.

Excellent problem-solving, analytical, and project management skills.

Strong communication skills, with experience collaborating in cross-functional teams.

Preferred Skills:

Hands-on experience with aseptic processing and cleanroom management.

Familiarity with microbiological and chemical testing procedures.

Lean Six Sigma or other continuous improvement methodologies.

Experience with process validation and cleaning validation in GMP environments.