Process Expert

Sterling Pharma Solutions; Ringaskiddy; On-site; EUR 50,000 - 70,000; Full time

Job summary

A global pharmaceutical company in Ringaskiddy, Ireland seeks a Process Expert to provide frontline support in manufacturing processes. The candidate will be responsible for maintaining quality standards and ensuring compliance with regulations while collaborating with manufacturing teams. Applicants should have a BSc in a relevant field and at least 3 years of experience in a GMP environment. Join a supportive team focused on bringing new medicines to market.

Qualifications

• 3+ years of experience in GMP manufacturing or QA/QC.
• Strong understanding of pharma processes and regulatory requirements.

Responsibilities

• Provide frontline support for process-specific issues.
• Support manufacturing teams to ensure safe and timely production.
• Maintain master manufacturing documents.
• Manage process changes and create SOPs.
• Evaluate product and process issues.

Skills

GMP knowledge

Process documentation

Data analysis

Root cause analysis

Education

BSc in Engineering or related field

Job description

Location: Ringaskiddy, Ireland

Department: Production

Reference: VN1029

Role Overview

The Process Expert will provide frontline support for all process-specific issues in production. The role ensures that processes are executed on time, with continuous improvements in quality and productivity, in compliance with cGMPs, SOPs, and applicable guidelines such as HSE and NOSSCE.

Responsibilities

• Provide support to manufacturing teams, focusing on safe, timely batch production in accordance with instructions and quality standards.
• Maintain master manufacturing documents, including Master Batch Records, Bill of Materials, Recipes, and risk assessments.
• Ensure critical parameters are within specified instructions.
• Manage process changes through proper change control procedures.
• Create and review SOPs and Master Batch Records.
• Act as Subject Matter Expert (SME) for products and processes, providing insights into process trends and innovations.
• Collect data for process verification and support product performance evaluation and CAPA implementation.
• Evaluate product and process issues such as deviations and complaints.
• Assist in assessing technical changes and conducting root cause analysis.
• Maintain processes at inspection readiness level.
• Support process optimization and new technology implementation.
• Review validation protocols and reports for accuracy.
• Assist in process validation and improvement projects, ensuring proper execution on the shop floor.
• Create and maintain master manufacturing documents.
• Provide input during process transfer and ensure process knowledge is thoroughly tested.
• Support training and education programs for production staff.

Requirements

• BSc in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or equivalent.
• Minimum of 3 years' experience in a GMP manufacturing or QA/QC shop floor role.
• Strong understanding of pharma processes, GMP, and regulatory requirements.

Why consider Sterling?

Sterling Pharma Solutions is a global CDMO with over 50 years of experience in developing and manufacturing APIs, including ADC research and development. We are a fast-growing company with facilities in the UK and US, employing over 800 passionate professionals dedicated to bringing new medicines to market and improving patient lives.

Our culture emphasizes delivering exceptional science and service, fostering a supportive environment where employees can thrive. Sterling Pharma Solutions is an equal opportunity employer, welcoming applications from all qualified candidates regardless of background.

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

Apply now.