About the Company
Summit Innovations Group is a leading innovator in advanced manufacturing technologies, dedicated to delivering cutting-edge solutions across various regulated industries. With a strong commitment to quality, precision, and continuous improvement, we empower our clients to achieve operational excellence. Based in Mansfield, Nottinghamshire, we foster a collaborative environment where talent thrives and contributions are valued.
Job Description
We are seeking a diligent and detail-oriented Validation Engineer to join our growing team in Mansfield, Nottinghamshire. This on-site role is crucial for ensuring the integrity and compliance of our manufacturing processes, equipment, and systems. The successful candidate will be instrumental in developing, executing, and reporting on validation activities, upholding the highest standards of quality and regulatory adherence.
Key Responsibilities
- Develop and execute validation protocols (Installation Qualification – IQ, Operational Qualification – OQ, Performance Qualification – PQ) for equipment, processes, and systems.
- Analyze validation data, write comprehensive reports, and present findings to cross-functional teams and management.
- Ensure all validation activities comply with internal Standard Operating Procedures (SOPs) and external regulatory requirements (e.g., ISO, GMP).
- Collaborate effectively with cross-functional teams including Research & Development, Quality Assurance, Manufacturing, and Engineering to support project timelines and deliverables.
- Manage and maintain accurate validation documentation and records throughout the lifecycle of equipment and processes.
- Identify and troubleshoot validation discrepancies, deviations, and non-conformances, implementing timely and effective corrective and preventive actions (CAPA).
- Stay updated with industry best practices, technological advancements, and regulatory changes related to validation and quality systems.
Required Skills
- Proven experience (minimum 3 years) in validation engineering within a regulated industry (e.g., medical devices, pharmaceutical, biotechnology, aerospace).
- Strong understanding of GxP principles, ISO standards (e.g., ISO 13485, ISO 9001), and other relevant regulatory guidelines.
- Extensive experience with IQ, OQ, PQ protocol development, execution, and report generation.
- Proficiency in data analysis and technical report writing, with the ability to clearly articulate complex information.
- Excellent problem-solving skills, a keen eye for detail, and a commitment to accuracy.
- Strong communication (written and verbal) and interpersonal skills to collaborate effectively with diverse teams.
Preferred Qualifications
- Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Chemical, Biomedical) or a related scientific field.
- Experience with risk assessment methodologies, such as Failure Mode and Effects Analysis (FMEA).
- Familiarity with statistical process control (SPC) and statistical software like Minitab.
- Professional certification in quality or validation (e.g., ASQ Certified Quality Engineer, CSQP).
Perks & Benefits
- Competitive annual salary and comprehensive benefits package, including private healthcare options.
- Generous pension scheme with employer contributions.
- Significant opportunities for professional development, training, and career growth within a dynamic organization.
- Work in modern, state-of-the-art facilities equipped with advanced technology.
- Join a collaborative, innovative, and supportive work environment.
- Access to an employee assistance program for personal and professional well-being.
- Free on-site parking for all employees.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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