A global medical technology company is looking for a Biochemist ( process integration)
Your new company
The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes.
Your new role
Biochemist – Process Integration is responsible to complete all assigned work in production and process transfer. The Biochemist will provide training to associates on all department technical and business procedures.
Review and maintain departmental data and update batch records/SOPs/WI. Will be expected to be able to identify potential problems, provide solutions and work independently to resolve issues with support of supervisors.
Primary Responsibilities and Duties
Demonstrates proficiency in all department related processes, with the emphasis on processes that are listed but not limited to:
- Coordinates and participates in product and technology transfer with Quality Control, Manufacturing, and other related functions.
- Contributes to guidelines, schedules and documentation of process and product transfers including and training of associates.
- Works to ensure transferred processes are capable of producing products that meet approved specifications and standards through adequate verification and validation practices.
- Participates in investigation and provides resolution to production and quality control issues for transfers and stable products.
- Performs cleaning, inspection, verification for calibration and maintenance of equipment. Maintains related logs and records. Performs equipment troubleshooting.
- Completes all relevant transactions on SAP system and performs the required inventory.
- Will participate in plant start up activities as assigned:
- Equipment setup and validation
- Layout and set up of lab and production areas
- SAP plant start up activities
- Promotes a safe work environment. Follow safety procedures. Participates in Environment Health and Safety programs.
- May generates Quality Reports such as Deviations Reports, etc.
- Active participant in the Continuous Improvement activities established in the plant.
- Executes assigned projects and communicates project status.
Requirements (Knowledge, Skills, and Abilities)
- Requires a Bachelor Degree in a related scientific discipline (such as Cell Biology, Chemistry, Biochemistry, Biology, Microbiology or Engineering) and a minimum of four years of experience in a pharmaceutical/ medical device / biotechnology industry or equivalent combination of related education and experience.
- Fully Bilingual (English and Hungarian).