Reporting to the Director, Manufacturing & Process, this position provides advanced technical leadership for the design, validation, optimization and continuous improvement of the manufacturing and conditioning equipment required for supporting the product’s performance in the field.
The role leads process development, equipment installation, and validation activities. The position requires deep expertise in equipment and process validation, regulatory compliance and continuous improvement in a multi-site environment. Travel to manufacturing and service sites, suppliers, and customer locations is expected.
Primary Duties and Responsibilities
Equipment & Process Validation
- Establish validation strategy for new equipment, process changes, and site transfers.
- Author and carry out equipment and process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Oversee revalidation strategy and change control impact assessments.
- Work with cross functional teams, service centres or customers to address validation deviations and corrective actions.
- Serve as engineering SME during internal and external audits.
Manufacturing Support & Technical Leadership
- Assist the Director, Manufacturing & Process in establishing validation strategy for new equipment, process changes and site set up.
- Define services, manufacturing and conditioning processes.
- Support production activities by troubleshooting equipment and process issues after initial evaluation and corrective actions have been performed by Operations or Maintenance personnel.
- Help create and maintain work instructions, standard operating procedures (SOPs), and manufacturing documentation.
- Collect and analyse production data to support process improvements.
- Lead complex engineering-level troubleshooting efforts following maintenance escalation
Quality & Compliance
- Follow established quality systems and manufacturing procedures to ensure compliance with internal and external requirements.
- Lead risk assessments (e.g., FMEA) for manufacturing processes and equipment.
- Lead audit preparation and provide documentation as needed.
Cross-Functional & Field Support
- Lead cross functionally with designated teams on assigned projects.
- Work with Engineering teams to ensure smooth introduction of new products into the business.
- Provide on-site engineering support at manufacturing and service facilities, suppliers, or customer locations as required.
- Lead equipment installation, commissioning, and process transfers.
Leadership & Development
- Mentor and develop junior engineers
- Provide technical training to operations and maintenance teams
- Lead cross functional project teams
Required Skills and Qualifications
- A bachelor’s degree in engineering (Masters preferred)
- 7+ years of manufacturing or engineering experience in a regulated environment
- Demonstrated leadership of equipment specification, installation and process validation (IQ, OQ, PQ)
- Willingness to travel up to 50%
Preferred Skills and Qualifications
- Proven leadership of equipment or process validation (IQ/OQ/PQ)
- Experience working alongside maintenance or operations teams in a manufacturing setting
- Demonstrated ownership of capital projects
- Experience of change control, lean six-sigma or process improvement tools
- Familiarity with regulated environments (e.g. ISO, GMP, GDP)
Additional Information
- Experience with temperature-controlled packaging is an advantage
- Strong attention to detail and communication skills
- Authors precise validation documentation and will make sound decisions under pressure
- Balances speed with compliance
- Drives tasks to completion while maintaining high standards
What we can offer you
- A competitive salary
- Company bonus scheme
- Hybrid Working
- Life assurance 4x salary
- Salary sacrifice pension
- Group income protection
- Development programmes
Travel Requirements
- Travel required – up to 50%
