Execution of routine and critical production operations
Learn and perform well-defined SOPs
Pursue on-the-job training through Competency Assessments to increase knowledge and understanding
Execute instructions and record data in the Electronic Batch Management (EBM) system if applicable
Execute instructions and record data in the Master Batch Records (MBRs) and
Master Formulation Records (MFRs) if applicable
Review manufacturing documentation and EBM or PCS alerts real-time to ensure compliance if applicable
Attain operating knowledge of the Process Control System (PCS)
Record data into logbooks and log-sheets
Review logbooks and log-sheets data
Perform equipment monitoring
Perform and coordinate basic laboratory tasks including but not limited to sampling, pH and conductivity measurements
Demonstrate aseptic technique in the handling of product and materials if applicable
Troubleshoot and resolve process related issues
Initiate and document production events in the Global Event Management System (GEMS) or equivalent system
Informing management of events impacting production schedule
Propose and review document revisions
Complete required training on time
Carry out work in a safe manner, notifying management of safety issues and risks
Qualifications
Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possesses 2 - 4 years of relevant experience in the biotechnology or pharmaceutical industry
Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition /
Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related and possess 4 - 6 years of relevant experience in the biotechnology or pharmaceutical industry
Nitec in Biotechnology / Chemical Process Technology or related with 6 - 8 years of relevant experience in the biotechnology, pharmaceutical industry
Excellent self-motivated team player with hands-on attitude and good communication skills
Able to work on rotating shift
Will work holidays and overtime as required
May be required to adjust work schedule to meet production demands
Key Skills and Competencies
Will be required to perform as a subject matter expert for equipment and/or systems
Proficient at following written instructions in the form of Electronic Batch Management (EBM), Batch
Records (MBRs, MFRs) and Standard Operating Procedures (SOPs) where applicable
Possess excellent communication skills
Possess excellent troubleshooting skills
Full awareness of current Good Manufacturing Practices (cGMP)
Proficient documentation and proficient computer skills
Proficient in aseptic technique where applicable
Experience as a system user of business systems such as C3ME and Trackwise
Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas
Ability to work in and out of 2-8 deg C Cold Rooms with appropriate personal protective equipment if required
Ability to work in confined spaces if required
Ability to work around chemicals (alcohols, acids & bases)
