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Process Engineer

Last Date: 31 Oct, 2025

Job Summary

Reporting to the Engineering Manager, the Process Engineer is responsible for supporting, optimising, and maintaining manufacturing processes within a medicines manufacturing, high-risk, regulatory-controlled, contamination-controlled environment. The role ensures that production processes operate efficiently, safely, and in compliance with GMP, MHRA regulations, and site quality standards, while driving continuous improvement across manufacturing operations.

This position plays a key role in process validation, troubleshooting, equipment optimisation, and technology transfer, ensuring consistent delivery of high-quality medicines.

Role and Responsibilities

  • Support the design, optimization, and control of manufacturing processes in contamination-controlled environments.
  • Assist with the qualification, validation, and routine monitoring of equipment, utilities, and processes to ensure compliance with regulatory-controlled requirements.
  • Collaborate with Production, QA, and Technical teams to ensure processes align with GMP and MHRA expectations.
  • Provide technical expertise in the investigation of process deviations, ensuring effective root cause analysis, CAPA implementation, and risk management.
  • Identify opportunities to improve efficiency, reduce waste, and enhance process reliability, while maintaining compliance and quality standards.
  • Draft and maintain Standard Operating Procedures (SOPs), validation protocols, and technical reports.
  • Provide engineering and technical support during internal audits and external regulatory inspections.
  • Monitor and trend process data to ensure data integrity and robust performance tracking.
  • Contribute to technology transfer, process scale-up, and new product introduction activities.
  • Support continuous improvement initiatives such as Lean Manufacturing or Six Sigma.

Knowledge, Training & Experience

  • Bachelor’s degree in chemical engineering, Process Engineering, Pharmaceutical Sciences, or a related discipline.
  • Experience in a GMP-regulated, medicines manufacturing, or contamination-controlled environment.
  • Strong understanding of GMP, MHRA requirements, process validation, and contamination control principles.
  • Practical experience in equipment qualification, cleaning validation, and deviation/CAPA management.
  • Strong analytical, problem-solving, and technical documentation skills.
  • Effective communication and teamwork skills to collaborate across departments in high-risk, regulatory-controlled environments.
  • Familiarity with Lean Manufacturing, Six Sigma, or continuous improvement methodologies is desirable.

Production Engineer

Last Date: 31 Oct, 2025

Job Summary

Reporting to the Engineering Manager, the Production Engineer is responsible for providing technical support to manufacturing operations within a medicines manufacturing, high-risk, regulatory-controlled, contamination-controlled environment. The role ensures production processes, equipment, and systems operate reliably, efficiently, and in compliance with GMP, MHRA regulations, and site quality standards.

This position is key to maintaining equipment performance, supporting process improvements, and ensuring that production activities consistently deliver high-quality medicines safely and compliantly.

Role and Responsibilities

  • Provide day-to-day engineering and technical support to production operations in contamination-controlled areas.
  • Ensure equipment and systems are maintained in a validated and compliant state, supporting preventive and corrective maintenance programs.
  • Support the installation, commissioning, and qualification (IQ/OQ/PQ) of new and existing production equipment.
  • Investigate and resolve equipment and process-related deviations, driving effective root cause analysis and CAPA implementation.
  • Partner with QA, Production, and technical teams to ensure compliance with GMP and MHRA regulatory-controlled requirements.
  • Monitor production performance metrics, equipment downtime, and reliability data to identify opportunities for improvement.
  • Draft and maintain Standard Operating Procedures (SOPs), engineering documentation, and technical reports in line with site standards.
  • Support continuous improvement projects to enhance efficiency, reduce costs, and strengthen contamination control.
  • Provide engineering input during internal audits and external regulatory inspections.
  • Contribute to training and knowledge transfer, ensuring operators and technicians understand equipment operation and compliance requirements.

Knowledge, Training & Experience

  • Bachelor’s degree in mechanical engineering, Production Engineering, or related discipline.
  • Experience in a GMP-regulated, medicines manufacturing, or contamination-controlled production environment.
  • Strong knowledge of equipment maintenance, reliability engineering, and contamination control principles.
  • Experience with root cause analysis, CAPA systems, and deviation investigations.
  • Familiarity with preventive maintenance systems (CMMS), equipment qualification, and validation processes.
  • Strong problem-solving, analytical, and technical writing skills.
  • Excellent communication and collaboration skills to work effectively across engineering, QA, and production teams.
  • Exposure to Lean Manufacturing, Six Sigma, or other continuous improvement methodologies is desirable.

Human Resources Industrial Relations (IR) Specialist

Last Date: 31 Oct, 2025

Job Summary

Reporting to the Site Director, the Human Resource Industrial Relations (IR) Specialist is responsible for leading and managing all aspects of employee relations, workforce engagement, and compliance with employment legislation at site level. This role is pivotal in maintaining a positive and compliant industrial climate within a high-risk, regulatory-controlled manufacturing environment, ensuring that HR practices align with both operational requirements and corporate objectives.

The Specialist will serve as the key advisor on industrial relations, conflict resolution, workforce compliance, and employee engagement, directly supporting the Site Director in building a resilient, engaged, and compliant workforce.

Role and Responsibilities

  • Act as the site lead for employee relations, serving as the primary point of contact for workforce matters.
  • Partner with the Site Director and leadership team to develop and implement site-wide HR and industrial relations strategies that support operational performance.
  • Provide expert advice on employment law, regulatory compliance, and HR policies in high-risk, contamination-controlled, and regulatory-controlled environments.
  • Oversee the management of grievances, disciplinary processes, and dispute resolution, ensuring fairness, consistency, and compliance.
  • Support change management initiatives, organizational restructuring, and cultural development programs at the site.
  • Monitor and report on workforce trends, IR metrics, and site-level compliance risks, providing insights and recommendations directly to the Site Director.
  • Ensure accurate HR documentation, data integrity, and adherence to regulatory-controlled record-keeping standards.
  • Deliver targeted HR and IR training to managers and employees to promote compliance, engagement, and awareness.
  • Actively contribute to site leadership meetings and decision-making forums as a strategic partner to the Site Director.

Knowledge, Training & Experience

  • Proven experience in HR or Industrial Relations, preferably within a regulated, high-risk manufacturing environment.
  • Strong knowledge of employment law, industrial relations frameworks, and HR compliance standards.
  • Demonstrated success in conflict resolution, grievance handling, and employee engagement initiatives.
  • Strong leadership presence with the ability to partner effectively with senior site leadership.
  • Excellent interpersonal, communication, and influencing skills to foster trust and collaboration across all levels.
  • Familiarity with ISO 9001, GMP-related HR compliance frameworks, or other regulatory standards is highly desirable.

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