Main characteristics
- Location
- Hertford, Hertfordshire
- Company
- Minstrell Recruitment Ltd
- Salary
- £55000 - £65000/annum Competitive Package
- Employment type
- Permanent
- Category
- Medical / Pharmaceutical / Scientific
Job summary
Computer Software Validation EngineerRole Purpose:
Review Pharmaceutical Machines against MHRA, FDA and GAMP compliance regulations and code of practice.
Salary: £55-65k (Perm 40 hours per week)
Location: Hertfordshire, Bedfrdshire, Berkshire. North London
Role Responsibilities:
1. Key Deliverable
* Validation of software and automation hardware for intended use and user needs. This includes testing R&D pilot plant machines under actual or simulated use conditions.
* Validation of computer system integrity to ensure accurate, reliable, consistent, secure deliverables of computer records and signatures against intended performance.
* Through understanding CSV-V model and its application in machine testing within the Pharmaceutical industry
1. Client Management
* Attend regular site reviews via Teams or in person at the clients or manufacturers site
* Validate process and documentation supplied against requirements and give expert feedback.
* Ensure Directors are kept up to date with progress.
* Present monthly client update at business meetings.
* Project management of technical deliverables against project plan
1. Relationship management
* Develop collaborative relationships that are effective for both the client and for employer.
* Understand clients values and motivations, ways of working and ordering processes; tailoring your approach to suit their requirements.
* Encourage and manage performance feedback from the client.
* Build a rapport with the internal team, providing effective line management; and support and mentorship to new team members as needed.
Person specification:
Qualifications
Essential
BSc Qualified in Controls, Automation Process Eng or similar
Manufacturing or Pharma background (3 years)
Automation Design and Commissioning
Hands-on, practical bias, can do attitude
Customer focus and delivery of results
Project Management
Desirable
GAMP or equivalent
Ethernet Protocols & data Comms eg OPC comms
Software backup and recovery
18th Edition or Plc training
Functional Safety and Machine Safety
Design Risk Assessment and CE marking
About the company:
They are one of the UKs leading manufacturing consultancies and employ engineers, project managers, technologists, and validation specialists. They help define capital investment projects, deliver them and track benefits with certainty. Their engineers install and validate advanced manufacturing technology from around the world.
They are a positive, look-ahead, company. People like to work for them. They invest in training and development and react swiftly to opportunities, make the most of good ideas, and play to peoples strengths.
The company has been established as an Employee Ownership Trust (EOT). This means that the business is owned by an independent trust which is tasked to act in the best interest of the employees. "employeeownership" website provides further information about the EOT philosophy and its practical impacts.
Exceptional benefits of this type of structure for both our employees and our customers include (subject to contract conditions):
* The long-term future and independence is secure.
* The structure demands an active employee representation and involvement through to the operating board.
* All employees are beneficiaries of the trust and business profits are re-invested and/or shared equitably among the employees (part of profit share payments are made free from income tax).
Ultimately, all the empoyees here have an equitable stake in the future and success of the business. If this sounds like something you would love to be a part of then we would like to hear from you
Benefits: Competitive Package
Inform me about similar jobs: