Operations Engineer – Buffer & Material Preparation

Role Purpose

As an Operations Engineer, you will provide process and technical support to the Manufacturing Operations Teams (Buffer and Material Preparation Operations) to enable the client to deliver its operational objectives.

Key Responsibilities

1. Shopfloor Operations

• Perform routine shopfloor operations such as buffer preparation, reactor cleaning, CIP (Cleaning-In-Place) and SIP (Sterilisation-In-Place) in accordance with GMP, EHS and site procedures.
• Execute manufacturing instructions, ensure adherence to batch records and promptly escalate any deviations or issues observed on the floor.
• Support line start-up, shutdown and changeover activities, ensuring equipment and systems are in a safe and compliant state for operation.
• Provide hands-on support during troubleshooting and recovery of process upsets, equipment alarms and operational interruptions.

2. Process & Technical Support

• Provide day-to-day process and technical support to Buffer and Material Preparation Operations to ensure safe, compliant and reliable production.
• Lead or support deviation investigations, including root cause analysis, implementation and effectiveness verification of CAPAs.
• Support equipment and process troubleshooting, working closely with Engineering, Maintenance and Automation teams to restore operations.

3. Change Management & Continuous Improvement

• Lead or support change controls related to equipment, process and/or incoming materials, ensuring appropriate technical assessment, risk evaluation and implementation planning.
• Identify and lead continuous improvement and process optimisation initiatives (e.g. yield improvement, cycle time reduction, robustness, right-first-time).
• Use data and structured problem-solving tools (e.g. DMAIC, 5 Whys, fishbone) to drive sustainable improvements.

4. Qualification, Validation & Projects

• Manage, schedule, coordinate and execute assigned qualification and validation activities (equipment, systems, processes) to ensure timely completion of the Validation Plan.
• Work with User, Engineering, Quality Control, Quality Assurance and Regulatory functions to ensure validation deliverables meet internal and external requirements.
• Ensure all process equipment and critical systems remain in a validated, inspection-ready state through appropriate lifecycle management.
• Contribute to cross-functional projects (e.g. technology transfers, new equipment introduction, digital/automation initiatives) as operations SME.

5. Quality, Compliance & Audit Readiness

• Ensure all activities comply with GMP, GSK internal standards and relevant regulatory requirements.
• Support audit preparation and management (internal, external, regulatory), including document readiness, walkthroughs and responses to observations.
• Maintain accurate and timely documentation in QMS (deviations, CAPAs, change controls, risk assessments, validation documentation).

6. EHS & Culture

• Promote and role-model strong Environment, Health & Safety (EHS) behaviours and compliance on the shopfloor and in project work.
• Participate in EHS risk assessments, incident investigations and improvement initiatives.
• Support and contribute to a positive site culture focused on safety, quality, continuous improvement and inclusion.

Requirements

Education & Experience

• Bachelor’s degree in Engineering or Science discipline (e.g. Chemical, Mechanical, Biotechnology, Pharmaceutical Engineering or equivalent).
• Fresh graduates with relevant degrees are encouraged to apply for junior roles; prior experience in pharmaceutical or biopharma manufacturing is an advantage.

Technical & Behavioural Skills

• Good troubleshooting and analytical skills, with a structured approach to problem solving.
• Comfortable with hands-on shopfloor work (e.g. buffer preparation, equipment cleaning, CIP/SIP) in a GMP manufacturing environment.
• Highly effective communication, facilitation, negotiation and teamwork skills.
• Excellent interpersonal, written and verbal communication skills.
• Adaptable to a fast-paced, dynamic work environment with shifting demands and priorities.
• Demonstrated continuous improvement mindset and willingness to learn new tools, technologies and ways of working.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.