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Join to apply for the Validation Engineering Manager role at CONVERGIX Automation Solutions
Reports to: VP Engineering
We are seeking talented individuals to join our growing team!
capable of solving any industrial automation challenge.
Role: Validation Engineering Manager
Location: Arbroath, Scotland
Reports to: VP Engineering
We are seeking talented individuals to join our growing team!
CONVERGIX Automation Solutions leverages the strengths, experience, and capabilities of our existing businesses, along with new talent, to transform and grow into the ultimate automation solutions trusted partner, capable of solving any industrial automation challenge.
As a Validation Engineering Manager you will be responsible for leading the validation team, engineering team and our customers in defining, executing and reporting on GAMP 5 validation activities associated with design and manufacturing of bespoke automation process equipment and machinery for life science applications.
What would a typical day look like?
* Manage a team of validation engineers in the comprehensive validation strategies and plans for life science systems, including defining the scope, approach, resources, and schedules to meet the customer User requirements.
* Manage and organise resources to meet project deadlines, budgets and customer requirements
* Ensure and deliver high levels of productivity and efficiency from the validation team
* Be an example of fair, assertive and effective leadership.
* Have responsibility for managing and approving timesheets, holidays and absence.
* Lead difficult conversations, including disciplinary and investigation for misconduct.
* Be responsible for increasing employee engagement within the Mechanical Design team, including educating and supporting the team in bi-annual eNPS surveys, and driving continuous improvement in this area.
* Validation Planning and Execution: Lead and Develop comprehensive validation strategies and plans for life science systems, including defining the scope, approach, resources, and schedules to meet the customer User requirements.
* Regulatory Compliance: Ensure all system validations are conducted in accordance with relevant regulatory requirements and industry best practices.
* Documentation Management: Manage the creation and review of all design, validation and operational documentation, including design specifications, validation plans, test protocols, and final reports.
* Coordination: Coordinate with cross-functional teams including Design, Project Engineering, IT, Quality Assurance, and Operations to ensure alignment on project goals.
* Risk Management: Conduct risk assessments and implement risk management strategies throughout the validation lifecycle according to GAMP 5 guidelines.
* Process Improvement: Continuously improve validation processes and procedures by implementing innovative approaches and adopting new technologies.
* Work closely with our customers to prepare and execute validation protocols for equipment and processes.
* Provide technical assistance and training to staff on validation systems and processes.
* Keep abreast of industry best practices and regulatory changes.
What qualifies you for this opportunity?
* You must be qualified to HNC level in an Engineering related subject. It is highly preferred that you have a Degree level qualification.
* Minimum 5+, Ideally 10 + Years Equipment Validation Engineer or similar role within life sciences.
* Strong knowledge of validation principles and regulatory guidelines. GAMP 5 and FDA 21 CFR PT 11. IQ/OQ/PQ processes.
* Experience in authoring URS, RTM, FMEA, FAT, SAT, IQ/OQ/PQ documents for life science
* Expertise in automated production processes and computerized systems.
* Proficient in validation software tools and applications. Minitab >16
* Excellent analytical, troubleshooting, and decision-making skills.
* Strong written and verbal communication skills.
* Experience and Knowledge of quality management systems to meet ISO 9001
* Knowledge of quality management systems to meet ISO 13485
* Minimum – Six Sigma Yellow belt
* Preferred – Six Sigma Green Belt or Black Belt
* Advantageous: Experience of SCADA systems and SCADA integration
* Advantageous: Experience of PLC and Vision system development and validation
* Advantageous: Experience of mentoring and developing technical personnel.
What We Expect From You
* A proactive can-do attitude.
* A positive and determined work ethic
* A professional approach
* A commitment to excellence in all that you do
* A team player, willing to continuously and proactively collaborate, share, and seek information and guidance
* Self-driven to make a significant contribution to maximising customer service
About Convergix Automation Solutions
Convergix Automation Solutions designs, engineers and integrates hardware and software to automate its customers' operations. Convergix specializes in creative, custom solutions and serves customers in a broad range of industries. With over 900 employees and 19 locations worldwide, Convergix is a leading global diversified automation provider. Our vision is to become the ultimate trusted partner, capable of solving any industrial automation challenge with our passionate people, world-renowned processes and diverse experience.
Learn more about us:https://convergixautomation.com/
What does CONVERGIX value?
Our values are our foundational concepts on which we build CONVERGIX; we adhere to these no matter what mountain we climb.
* Integrity - Respect, Transparency, Commitment
* Excellence - Continuous Improvement, Innovation, Collaboration, Communication
* Passion - Momentum, Sense of Urgency, Growth, Success, Velocity
We thank all candidates for their interest, however only those considered for an interview will be contacted.
CONVERGIX Automation Solutions has a programme in place that provides reasonable adjustments for employees with disabilities. If you require a specific adjustment because of a disability or a medical need, please contact Human Resources.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Information Technology
* Industries
Automation Machinery Manufacturing
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