Job Description
We are seeking a highly skilled Process Validation Engineer to join our Manufacturing Engineering Team based nearSouthend-on-Sea, UK. This pivotal role involves owning all aspects of process validation within the manufacturing environment, ensuring our processes are fully validated for production use in strict compliance with regulatory standards.
Responsibilities
* As the Process Validation SME, you will be responsible for ensuring the validation of manufacturing processes, focusing on regulatory compliance, process integrity, and continuous improvements.
* Validation Leadership: Take the lead in the creation and execution of the Site Master Validation Plan. This includes planning, developing risk-based protocols, and overseeing specific validation activities while also supporting and guiding validation efforts carried out by other engineers.
* Project Support & Process Enhancement: Collaborate with project teams and production departments to provide process validation expertise for development projects, continuous improvement initiatives, and change management activities.
* Regulatory Guidance: Offer expert advice on process validation, ensuring compliance with relevant regulatory standards. Your input will be crucial in maintaining the quality and compliance of manufacturing processes.
* Documentation & Approvals: Lead the creation of risk-based validation protocols, reviewing and approving validation documentation. You will be responsible for ensuring all documentation meets the necessary quality and regulatory standards.
* Coaching & Knowledge Sharing: Provide coaching and mentoring to less experienced engineers, fostering a collaborative environment that promotes knowledge sharing and team development.
* Statistical Methods: Apply statistical tools and techniques within validation activities to ensure processes are verified and validated accurately and effectively.
* Audit Representation: Represent the Process Validation function during both internal and external audits, ensuring that validation processes meet all regulatory requirements and industry standards.
What do we need from you?
* Educational Background: Minimum of HNC or higher in an Engineering discipline (Mechanical, Electrical, Manufacturing, or a related field).
* Relevant Experience: Proven track record in an engineering or manufacturing environment, with deep expertise in process validation. You should have experience in planning, creating, executing, and maintaining validation protocols.
* Technical Expertise: Strong technical skills, including the ability to interpret engineering drawings. Proficiency in Microsoft Office and a strong understanding of statistical methods for process validation are essential.
* Communication Skills: Excellent written and verbal communication skills, with the ability to clearly articulate complex technical concepts to both technical and non-technical stakeholders.
* Team Collaboration: A proactive and collaborative approach, with the ability to work independently as well as part of a team.
Package
* Up to £60,000 basic salary with flexibility for exceptional candidates.
* Relocation Assistance: Reimbursement scheme available for relocation costs (up to £12,000).
* Generous Benefits:
* 26 days of annual leave plus bank holidays.
* Defined contribution pension scheme with employer match up to 12%.
* Private medical and dental coverage (optional participation).
* Annual health checks, employee assistance programs, and discounted gym memberships.
* Enhanced parental leave.
* Subsidised on-site staff restaurant.
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