Project Information: Production facility in St. Petersburg (Russia) Novartis is searching for qualified and highly motivated specialists.
Position: Process Expert (Младший инженер-технолог)
Position Goal: Provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines and normatives.
Temporary position for 2 years!
Key Job Responsibilities:
Shop floor support:
- Provide front line support to manufacturing, working with the shift teams, , focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
Validation - execution and review of protocol/report:
- Support the execution of process validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shopfloor to ensure accurate execution.
- Review and assure that validation protocols and report are technically correct.
- Ensure protocols are executed as intended.
Technical improvement execution:
- Execute process improvements, scale-up.
- Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables.
Primary packaging closure assessment during changes:
- Evaluate and assure, in case of packaging change, that the primary packaging closure - including materials - are sufficient to ensure stability of the product and do not deteriorate quality.
Assure consistency of Master Batch Records:
- Ensure that all critical and significant parameters are within written Instruction (i.e. Master Batch Record, Validation Plan), sufficient and appropriate for the product.
Deviation, Out Of Expectation, Out Of Specification, complaint handling:
- Lead product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification.
- Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.
- Provide training for assigned new processes and products.
- Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining this position.
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
- Desirable MSc. or equivalent experience. Proficient in site local language and English skills a bonus.
- 3 years experience desirable in process support role on the shop floor of GMP manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
- English skill is a bonus.