DP Engineer - Formulation

Description

• Prepare and execute cGMP documentation, including risk assessments and associated reports.
• Provide technical leadership for formulation equipment and processes within the Drug Product manufacturing area.
• Contribute to establishing a new Preventive Maintenance (PM) programme for Drug Product equipment.
• Identify opportunities for process and equipment optimisation and translate these into CI initiatives.
• Ensure all equipment installed is safe, effective and compliant with applicable standards and engineering procedures.
• Maintain validated equipment status by executing revalidation protocols in alignment with the site Validation Master Plan.
• Provide technical support during regulatory inspections, defending systems, investigations, validations and change controls as needed.
• Apply structured problem-solving and continuous improvement tools such as DMAIC and FMEA to drive operational excellence.
• Manage equipment or process changes through the site change control system.
• Troubleshoot equipment and process issues, collaborating with cross-functional teams to implement effective corrective and preventive actions.
• Lead and support technical investigations, ensuring root cause analysis, impact assessment and appropriate CAPA implementation.
• Manage equipment vendors, including oversight of maintenance activities, continuous improvement projects and spare part criticality assessments.
• Support the development, review and execution of testing protocols, reports and manufacturing documentation.
• Support batch disposition by resolving technical or engineering issues encountered during processing.
• Assist in the transition from project start-up to sustained manufacturing operations, supporting scale-up and long-term equipment reliability.
• Participate in TPM, CI and Gemba activities, and engage in daily and weekly tiered manufacturing meetings.

Requirements

• Knowledge and application of risk-based tools such as FMEA.
• Bachelor’s degree in Engineering, Science or a related technical discipline.
• Experience with autoclaves, parts washers and CIP/SIP systems.
• Experience executing FAT, SAT, IQ and OQ in an operational setting.
• Minimum 5 years’ engineering experience in a cGMP manufacturing environment.
• CQV experience is desirable.
• Familiarity with regulatory frameworks such as Annex 1 is beneficial.
• Knowledge of formulation processes and associated equipment.
• Demonstrated experience resolving complex technical investigations.
• Strong background in structured problem solving and CI methodologies (e.g., Six Sigma).

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance