Manufacturing and Validation Engineer
8 days ago
Long Crendon
CSafe are an award-winning temperature control-packaging innovator that have been designing and producing high performance passive temperature control packaging systems for over 20 years. We offer consistent quality to our clients from our strategically located global manufacturing sites throughout EMEA, Americas, India, and Asia Pacific. We have formed long standing partnerships with the world’s leading biotech, pharmaceutical, clinical research, and logistics companies, and apply innovative thinking to overcome the challenges that our clients face in managing the Cold Chain when shipping temperature sensitive commercial and clinical trial products. Job Purpose The Manufacturing Engineer is responsible for establishing and maintaining a documented evidence trail through inspection, testing, and verification activities to demonstrate that manufacturing equipment, systems, procedures, and processes used in the production of CSafe products consistently deliver repeatable outputs that meet defined quality requirements. This role supports CSafe manufacturing facilities and key supply chain partner locations, driving continuous improvement initiatives and managing controlled change processes. The Manufacturing Engineer ensures the consistent, compliant, and efficient supply of CSafe products across all operational sites. Main Tasks and Responsibilities • Support the implementation, qualification, and ongoing validation of manufacturing processes for both existing and new products and suppliers., • Prepare and execute validation activities (IQ, OQ, PQ) at CSafe and supplier manufacturing facilities, as required., • Develop and execute validation plans, manufacturing process flows, specifications, work instructions, and quality plans., • Provide process expertise and technical support for manufacturing equipment and production processes., • Review design proposals and technical specifications to ensure manufacturability using appropriate tools such as DFMEA., • Define equipment user requirements specifications (URS) and contribute to cost estimates., • Evaluate and select equipment suppliers against defined specifications and manage suppliers through project completion., • Build and maintain strong working relationships with suppliers to ensure successful project outcomes., • Plan and execute approved projects (existing and emerging technologies) to agreed targets for cost, timeline, and performance., • Lead, manage, and communicate validation project activities, including regular status updates to project managers, and sponsors., • Ensure all equipment documentation—from specification through validation and production handover—is complete, compliant, and properly archived., • Support regulatory audits, submissions, and auditor requests; ensure compliance with GMP, ISO, environmental, statutory, and safety requirements., • Ensure production processes are safe and robust using appropriate tools such as risk assessments and PFMEA., • Identify and implement continuous improvement opportunities to enhance process capability, efficiency, and cost performance., • Train internal and external production staff on process instructions, best practices, and validation requirements., • Collaborate cross-functionally with Supply Chain, Operations, Quality, Facilities, Finance, Engineering, and Logistics teams to achieve departmental and organizational goals., • Follow company policies and procedures as outlined in the employee handbook and adhere to all safety and regulatory guidelines., • Actively supports and complies with CSafe objectives, guidelines and commitment to Quality and Safety, with an emphasis on continual improvement., • Must be able to interact effectively and cooperatively with employees at all levels., • Must have the ability to complete assignments within the timeframe specified by the Manager., • Must be able to operate in a fast-paced environment and handle multiple projects simultaneously., • Must be flexible regarding working hours as needed to be successful in the position., • Emphasizes ethical leadership and decision-making to protect the CSafe brand and reputation., • Perform additional duties as assigned. KPIs KPIs will be focus on both equipment & process validation… Equipment Validation- • Overall Equipment Effectiveness (OEE): The "gold standard" metric, calculating the percentage of planned production time that is truly productive (Availability Performance Quality)., • Cycle Time: The time taken to complete a manufacturing process or operation from start to finish., • Throughput: The amount of product produced over a specific period (e.g., units per hour)., • Production Schedule Attainment: Measures how often the production team meets target production levels for a specific period., • Capacity Utilization: The ratio of actual output to potential maximum output. Process Validation • First Pass Yield (FPY) / Right First Time (RFT): The percentage of products that meet quality standards on the first attempt without needing rework or repair., • Defect Rate / Scrap Rate: The percentage of defective products or components compared to total production., • Non-Conformance Rate: Frequency of failures to meet specified requirements., • Validation Cycle Time: Time taken to complete IQ/OQ/PQ (Installation, Operational, Performance Qualification) phases., • Deviation Rate: Number of deviations from standard operating procedures (SOPs) during validation. Functional Competencies • Degree in Engineering or an equivalent recognized engineering qualification, with 5–8+ years of relevant experience in an engineering role, • Strong knowledge and firsthand experience in:, • Process engineering, • Validation engineering, • Technical document writing, • Risk analysis methods (including PFMEA and DFMEA), • Demonstrated experience in equipment specification, procurement, installation, and commissioning projects, • Internal and external auditing experience., • Ability to interpret technical documentation and drawings, • AQPQ (Advanced product Quality Planning) knowledge & experience, • PPAP (Production Part Approval Process) knowledge & experience, • Excellent teamwork and team-building skills with a proactive, “can-do” attitude, • Strong written, verbal, and presentation communication skills, • Proven ability to identify and resolve problems in a timely manner using structured, evidence-based problem-solving approaches, • Experience in medical device, aerospace, automative, pharmaceutical packaging, including sealing equipment, automation, and robotic technologies Behavioral Competencies • A logical fact-based problem solver able to weigh up pros and cons and make reliable choices, • Able to proactively set goals and support staff to deliver them in a collaborative manner, • Drive to achieve results - sets own standards, checks own work, and demonstrates a positive approach, • Ability to work to tight deadlines and handle high volume workloads, • Strong communication skills with the ability to influence and guide the team and other departments, • Judgement and decision making - evaluates key decision-making criteria, • Working collaboratively - actively contributes to achieve organizational objectives, • Confident, proactive and customer focused approach, • Process driven with the ability to drive continuous improvement, • Team working – drives to deliver result through teamwork, • Excellent verbal and written communication skills, • Ability to demonstrate strong and inspiring leadership skills, • Ability to train and mentor to achieve maximum performance Other Requirements • Full driving license, • Willingness and ability to travel nationally and internationally for supplier visits and equipment validation activities, as required
