Process Technician (Kilo Lab) - cGMP Manufacturing

About the role

Eurofins CDMO Alphora develops and manufactures new therapeutics for pharmaceutical and biotech clients, producing bulk drug substances (APIs) and finished dosage forms. The Process Technician (Kilo lab) works as a team member on a shift under the direction of the Shift/Team Leader, executing production batches at cGMP manufacturing facilities. The role supports departmental initiatives in a fast-paced environment while following cGMP, EHS and company practices.

Key responsibilities

• Execute chemical processing operations according to batch record instructions and complete batches accurately and on time.
• Follow environmental, health and safety procedures, standard operating procedures, batch records, good documentation and manufacturing practices, including second-person verification where required.
• Accurately and contemporaneously enter batch sheets.
• Set up and inert process equipment and perform routine unit operations under supervision such as filtration, phase separation, refluxing, atmospheric and reduced-pressure distillation.
• Clean chemical processing equipment and facilities.
• Work with Technology Transfer, Engineering/Maintenance, Quality Assurance, Quality Control and R&D, and support exception management and continuous improvement.

Required profile

• College diploma or degree, with 2-5 years of experience in a chemical manufacturing facility (cGMP experience preferred).
• Experience with high-potency APIs in isolators is preferred.
• Experience with small-scale glassware (1-5 L reactors), small-scale purification units (e.g., Biotage Isolera) and prep LC is desirable.
• Experience handling hazardous chemicals and process waste, and with computerized chemical processing equipment.
• Shift work: availability for continental 12-hour day, afternoon and night shifts on a biweekly rotation.

Required skills

• Solid understanding of cGMP principles (prior QA/compliance experience is a definite asset).
• Proficient written and verbal skills, multitasking and sound decision-making.

What we offer

• Approximate annual base compensation starting at $50,000 CAD, with shift premiums and overtime possible.
• Health and dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays and paid time off.