Process Expert

Role Overview:

The Process Expert will 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).

Responsibilities:
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.
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 instructions.
Ensure that all process changes in assigned products are managed through appropriate change control procedures.
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.
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 optimization establishment and new technology introduction for continued productivity improvement, as appropriate.
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.
Be knowledgeable of process design by providing input during process transfer.
Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables.
Support technology trainings and education programs for production operators.

Requirements: BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
Minimum 3 years experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
Proven process understanding (Pharma, GMP, Regulatory aspects).

Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast-growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.

Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.

Be caring. Be transparent. Be willing. Be reliable.
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