Guidant IRC are hiring on behalf of Novartis for the position of a Process Engineer within the Pharmaceutical industry.
Job Type: Fixed term 12-month contract
Start Date: ASAP
Location: Cork, Ringaskiddy
Holiday entitlement: 25 days
The work of a process expert is underlined in the success of every drug launch in the pharmaceutical industry. This role will provide process related engineering support as well as technical support within the Manufacturing Unit. 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 productivity, performance in compliance to cGMPs. SOPs and applicable guidelines and functional standards. (E.g. HSE, NOSSCE).
Key role requirements:
At least 3 years in a process support role on the shop floor of GMP manufacturing and/or QA/QC.
Proven process understanding (Pharma, GMP, Regulatory aspects)
Education & Qualification:
BSC. In Engineering, Pharma Technology, Chemistry, Pharmacy or equivalent scientific degree.
- 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 measure's
- Responsible for maintaining the master manufacturing documents of assigned products (e.g., Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment, Zurich Hazard Analysis)
- Ensure that all critical parameters are within written Instruction (e.g., Master Batch record, Quality Risk Assessment, Validation protocol).
- support steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
- Ensure that all process changes in assigned products are managed through appropriate change control procedure.
- Ensure creation of production SOPs, and Master Batch records.
- Act as Subject Matter Expert (SME) for the product and process knowledge, be Highly knowledgeable of product and process trends by proving input to APQR for analysis and for driving process technology innovations.
- Collect data for ongoing process verification (OPV), support product steward in tracking and evaluation of product performance and implementation of CAPAs.
- Perform first line evaluation of product and process related issues (deviations, complaints,OOS,OOE).
- Support product steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
- Maintain processes at inspection readiness level.
- support process optimisation establishment and new technology introduction for continued productivity improvement, as appropriate.
validation - for the products) assigned:
- Review validation protocols and reports for technical correctness.
- support the execution of process validations, and short-term improvement projects, liaising with the relevant parties at shop floor to ensure accurate execution.
Launch &Transfer- for the product) assigned:
- Responsible for creating the master manufacturing documents of assigned products, as appropriate.
- Be knowledgeable of process design by providing input during process transfer.
Manufacturing Excellence- for the product (assigned:
- Execute process improvements and scale-up.
- Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables. Training:
- Own the Training Curriculum for own Job profile.
- support technology training's and education programs for production operators.
Key Performance Indicators
- Batch release on time/in quality.
- Batch record RFT.
- Line throughout time.
- Number of Deviations.
- Effective CAPAS.
- PpK/Cpk- Process capability.
- Oos, OOE-Out of specification, out of Expectation- process elated.
- customer complaints- process-related.
- Number of Recalls - process-related.
- success rate of internal audits and Health Authorities inspections.
Guidant IRC is acting as an Employment Business in relation to this vacancy.
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