Production Technical Specialist at The Biovac Institute

Job description

The Key Performance Areas for this position include:

• Technology Transfer Execution and SME Management of Assigned Processes or Equipment
• Assist the Qualification and Validation sections with writing, review and/or execution of appropriate documentation required for-, Installation-, operational and performance qualifications (DQ, IQ, OQ, PQ) and or process validation (PV) protocols of packing and inspection equipment.
• Witness Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs).
• Review protocols for FATs and SATs.
• Ensures that PPMs are ordered on time to execute packing runs for trials required during technology transfers.
• Works closely with the Team Lead and Site Advisor/Project Manager to ensure that activities are executed as per agreed time lines and standard.
• Liaise closely with technology transfer partner to ensure that expectations are met.
• Write SOPs for automated cartoning, labelling, thermoforming and inspection equipment and train applicable staff to run and maintain the equipment.
• Adhere strictly to SOPs, Work Instructions Manufacturing Batch Records (MBRs) or other process-related specifications.
• Make basic software changes on the computer interface/HMI of above mentioned equipment. Interpret complex process-related data from the HMI and raise alarm if necessary. Advise, Project Manager, Section Head and Department Manager in time of any bottle necks that might delay time lines.
• Review artwork to ensure that it is aligned with equipment installed in the VLP section.Identify potential problem areas, ensuring early detection or diagnosis and implementation of solutions.
• Ensure non-wastage of materials and components.
• Lead investigations pertaining to deviations.
• Provide technical feedback and advice when necessary to Supervisor, Engineering or service provider.
• Quality Performance
• Is up to date with latest cGMP requirements for pharmaceutical packing.
• Ensures that all assigned documentation e.g. change controls, deviations, SOPs etc. is of an acceptable quality, aligned with cGDocP and Biovac’s internal control procedures and agreed time lines, to ensure cGMP compliance at all times and minimise possible audit findings.

Knowledge / experience

• Technical aptitude – mechanical and electrical processes.
• Experience in running and operation of automated thermoformer, labelling, cartoning and visual inspection equipment
• Labelling, cartoning and blistering/thermoforming systems
• Process design for automated packing, labelling, blistering and visual inspection equipment
• Experience in the pharmaceutical industry would be preferred
• Compliance orientation
• Good time management
• Must be available to work shifts or after hours

Qualifications and Skills Required

• Experience in establishing automated pharmaceutical packing lines, especially labeling machines, inspection machines, thermo former and cartoning machines and process design and metronics.
• Engineering Degree / Diploma (Mechanical/Electrical) with specialization in packng or equivalent (N4 and above).

Other requirements

• Local and international travel may be required.
• Own, reliable transport required for possible standby and shift work.