Job Title
- Manufacturing Operator
- Production Operator
- Production Associate
- Production Technologist
Educational Background
- College degree/ diploma
- B.Sc.
- B.Eng.
- High School (mostly cannabis industry or cosmetic industry)
Job Functions
- Set-up, operate, maintain, assemble and disassemble production equipment as needed as per company standard operating procedures (SOP’s) and regulatory standards (GMP).
- GMP gowning is mandatory as you will be working in the GMP area.
- Perform manufacturing process steps of a dosage form by strictly following written procedures such as ‘master production batch record’ and the related SOPs. Example: Tablet manufacturing process steps involve dispensing, blending, wet/dry granulation, compression, coating.
- You will need to operate equipment, lift objects/ drums, climb, stand for a long period of time.
- Clean equipment after use as per the cleaning procedure.
- Working safely is very important.
- Perform in-process testing at each step as per the master production batch record and the related SOP. Depending on the in-process test results, make the necessary adjustment to the parameters to meet the specification.
- Perform batch reconciliation.
Must Have Skills
- Mathematical skills
- Able to stand for a long period of time, climb and lift/ move materials, objects and drums containing in process product from one area to another.
- Must be okay to work in an environment that requires GMP gowning and do shift work
- Detail oriented and ability to follow written procedures without any deviation
- Work well under pressure and in a ‘fast paced and minimal tolerance for mistakes’ environment
- Able to do the same task over and over again
- Honest and transparent
- Able to take responsibility for your own action
- Work well individually and as part of a team
- Professional, fast learner and takes initiative
- Able to work in a highly regulated environment and follow company Standard Operating Procedures (SOPs), regulatory guidelines and safety standards.
Type of Companies that Hire
- Pharmaceutical/ Biopharmaceutical
- Contract Labs (with manufacturing ability)
- Cannabis Industry
- Food Industry
- Cosmetic companies
- other
Competitive Advantage
- knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), FDA, Health Canada
- any transferable skills that speak for your ability to follow instructions and written procedures without any deviation
Career Growth
Operator –> Senior –> Supervisor (B.Sc./ B.Eng.) –> Director / VP
Other options (most of these will require university degree):
–>transfer to QA department as QA Associate/ Document Reviewer for manufacturing (competitive advantage: certificate/ courses taken/ diploma in Quality Assurance
–>transfer to QC lab as QC chemist (competitive advantage: courses taken on HPLC with hands on experience)
–> transfer to Validation or Technical Services department (best option for B.Eng.)
–> B.Eng could also consider working for the equipment manufacturers and suppliers, in the R&D department or as field service engineers/technicians.
–> if you have certification on project management and preferably PM certified, consider becoming a Project Manager
–> with business certification, you could even transfer to business side of the pharma
Recommended Readings
- USP <1151> Pharmaceutical Dosage Forms –> If you have an interview, look up the company and find out what type of dosage forms they make. If they make tablets, read the section on tablets.
- Facts About the Current Good Manufacturing Practices (CGMPs)
- USP <1029> Good Documentation Guidelines