Chemical Engineer
Peakhurst, NSW
Phytex manufactures some of the highest quality Active Pharmaceutical Ingredients in the world extracted from Australian native flora so our clients can make medicines to improve people’s wellbeing. We are a specialised business, proudly Australian owned and operated with more than 30 years history of delivering our products to global pharmaceutical markets and the research community.
We are seeking a highly motivated & experienced Chemical Engineerto join our team on a full-time basis, working 38 hours per week based in Peakhurst, NSW.
About the Role
As a Chemical Engineer, you will play a central role in managing the company’s manufacturing & production functions. Your key responsibilities will include scheduling and completing production runs, ensuring GMP compliance in the production environment, optimizing manufacturing processes to improve yield and reducing cost, and managing the documentation of all facets of the production to GMP regulatory requirements.
Key Responsibilities & Duties
Day to day tasks will vary, however you will be primarily responsible for the following tasks which include but is not limited to:
· Plan and schedule production in collaboration with Manufacturing, Quality Assurance, and Quality Control teams, ensuring effective and proactive interaction.
· Drive the validation of GMP processes and qualification of appropriate equipment, prepare and review process validation report, risk assessment and product quality review.
· Design and complete scale up production runs, ensure procurement of appropriate equipment and access to utilities.
· Develop and communicate compliance policies and standards, provide guidance and training as appropriate.
· Ensure compliance of products and processes with all relevant GMP and regulatory requirements as stipulated by Competent Authorities in the various jurisdictions where product is sold and section 2.2 of the code of GMP and ICH-Q7 guidance.
· Ensure that the company's Quality Assurance/Quality Control policies, management systems and strategy are implemented, followed and maintained.
· Supervise and assist any Production Assistant staff to ensure successful completion of any assigned tasks.
· Prepare for manufacture and postproduction cleaning by ensuring availability and stock of all required solvents/equipment/utensils/raw material products and the effective function of all required machines and tools.
· Monitor GMP production runs and ensure all process specifications are met, assist QC in the sampling of raw materials and in-process products.
· Precisely update, implement, and ensure operators follow controlled SOPs and Manufacturing Directions and complete documentation requirements including cleaning of equipment and facilities.
· Assist the Quality Unit in the investigation of manufacturing deviation and non-conformances, implement controls and corrective actions to reduce failure rate.
· Develop, deliver, and evaluate training to employees for relevant manufacturing, quality & regulatory requirements.
· Ensure WH&S standards are always adhered to.
Skills & Experience – Who we’re looking for:
For this position, it is expected that you would possess the following qualifications/work experience:
· Minimum Bachelor level degree in Chemical Engineering, Sciences, Life Sciences or relevant field
· Minimum 3 years’ experience working in comparable role, preferably in Pharmaceutical, GMP, food manufacture, veterinary or medical devices environment
· Experience in engineering, validation, scheduling and organization of teams to meet desired deadlines
· Practical GMP specific experience with mechanical aptitude and practical experience/initiative
· Demonstrated track record in assisting management to improve Quality performance
· Advanced computer skills (Office) including word processing, database management and Microsoft Office suite of products
· Ability to learn and apply other industry related technologies, processes and concept
· Critical thinking, process analysis, and problem-solving skills
· Strong organizational and scheduling skills
· Ability to work to realistic scheduled timelines and prioritise tasks to meet deadlines
· Ability to interpret regulatory guidelines and implement the required system(s)
Summary of role requirements:
- Looking for candidates available to work:
- Monday: Morning, Afternoon, Evening
- Tuesday: Morning, Afternoon, Evening
- Wednesday: Morning, Afternoon, Evening
- Thursday: Morning, Afternoon, Evening
- Friday: Morning, Afternoon, Evening
- 2-3 years of relevant work experience required for this role
- Working rights required for this role
- Expected start date for role: 26 June 2024
- Expected salary: $80,000 per year