Process Expert DSP - Biopharmaceutical Processes and Manufacturing

Job description

Job Description

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 productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE, (Supply Chain MRPII Class A)).

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 providing 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.
• Support steward for assessment of deviations and perform first line evaluation of product and process related issues (deviations, complaints, OOS, OOE).
• Maintain processes at inspection readiness level.
• Support process optimization establishment and new technology introduction for continued productivity improvement, as appropriate.

Validation – for the product(s) assigned:

• Review validation protocols and reports for technical correctness.
• Support the execution of process validations, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution.

Transfer & Launch– for the product(s) assigned:

• Technical expert to evaluate transferred parameters and plant fit
• 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(s) 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 trainings and education programs for production operators.

Desired profile

Minimum requirements

• BSc. in Biotechnology, Pharmaceutical Technology, , Pharmacy or equivalent scientific degree.
• Desirable MSc. or equivalent experience.

Fluent in English and proficient in site local language (German).

• Minimum 3 year experience in process support role including the shop floor of GMP manufacturing
• Proven understanding DSP processes.
Experience in USP and cell-banking is an advantage
• Proven process understanding (Pharma, GMP, Regulatory aspects).