Process Engineer

About BioCina

BioCina is a global end-to-end biologics Contract Development and Manufacturing Organisation (CDMO) of choice, offering high-quality, cost-effective cell line development, process development and cGMP clinical & commercial manufacturing for the microbial, pDNA and mRNA modalities. Our US FDA, EMA and TGA approved site in South Australia, which was previously a Pfizer facility, is staffed with a tremendously experienced technical and operations team, with most critical SME’s having an average tenure of 15+ years at the Adelaide site. To address the ever-evolving requirements of our current and future clients, we are adding a 2000 L microbial fermenter and large-scale mRNA manufacturing in our Adelaide facility, and we will be establishing a second facility with Mammalian PD and large-scale manufacturing.

We are seeking a qualified and experienced Process Engineer to join our Process Development Team in the scaling up, optimization, and monitoring of processes within Production, process transfer contributing to the design, functionality, safety, and risk assessment of processing equipment and achievement of agreed key performance indicators and company goals. 

Responsibilities

• Design, execute, and analyze engineering studies to commission and/or optimize manufacturing equipment and processes.
• Review process and equipment performance to ensure the maintenance of consistent process operation. Optimise process performance to enhance process consistency and reliability using techniques such as Six Sigma and 5S.
• Review new and existing equipment to ensure it meets EHS guidelines and implement measures to improve safety where practicable.
• Prepare equipment User Requirements Specifications, communicate with vendors, and compare vendor proposals. Contribute to the functional design of equipment. Prepare commissioning and testing documents and participate in their execution.
• Liaise closely with the Process Development and Production departments for the transfer of manufacturing processes from lab-scale to production-scale.
• Prepare draft Batch Records and Standard Operating Procedures for development batches at the production scale and make amendments as experience is gained at the production scale.
• Assess equipment capacity, raw materials requirements, and logistical issues related to materials handling, process volumes, process timing, and differences between lab-scale and production processing methods.
• Preparation of documentation for new processes, investigation of process failures, and staff training.

Qualifications 

• Bachelor’s or associate's Degree or Master of Life Sciences or equivalent.
• Minimum 5 years of relevant experience in Process Engineering.

Personal characteristics that are important for the role

• Strong technical skills and understanding of chemical engineering principles such as fluid flow, heat transfer, chemical reactions, process control systems, automation, risk analysis, and process safety.
• Strong self-organization and leadership skills, ability to prioritize and juggle multiple tasks.
• Excellent communication and interpersonal skills.
• Highly pragmatic approach
• Ability to generate multiple practicable solutions to open-ended problems with incomplete, ambiguous, or conflicting information.
• Strong troubleshooting skills

Experience which will be an advantage

• Experience in the field of Biotechnology - especially microorganisms, recovery of bio-molecules including chromatography and tangential flow filtration, or biopharmaceutical manufacturing.
• Strong understanding of quality systems including handling of process deviations, change controls, and quality records.
• Knowledge and experience in Good Manufacturing Practice (GMP).

Why work with BioCina?

• Competitive remuneration and benefits:  We offer a competitive salary, a comprehensive benefits package, and recognition for exceptional performance.
• Flexibility: We offer significant flexibility in working hours and the ability to work from home/work remotely.
• Career growth opportunities:  We believe in growing our people and providing ample opportunities for career development and advancement.
• Innovation and impact:  Be part of a company that goes beyond the boundaries of science and makes 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 share a common goal.
• Diversity: We are highly diverse in gender, ethnic background, age, and personality types, and we will value the individuality you bring to the team.

Join our team and help shape the future of biopharmaceuticals.  Together, we can make a difference.

To apply, please submit your resume and a cover letter outlining your qualifications, relevant experience, and why you are the right fit for this role. We thank all applicants for their interest, but only shortlisted candidates will be contacted.

As part of our commitment to creating a diverse and inclusive workplace, BioCina is an equal opportunity employer and seeks to have a diverse candidate shortlisted for this vacancy. All experienced candidates from a range of backgrounds, including genders, people with disabilities, and indigenous and ethnically diverse candidates are encouraged to apply.