Computer Software Validation Engineer - Pharmaceutical
Role Purpose:
Review Pharmaceutical Machines / Equipment against MHRA, FDA and GAMP compliance regulations and code of practice.
Salary: Circa £55K (Perm 40 hours per week)
Location: WFH and Hertfordshire (Hybrid)
Role Responsibilities:
1. Key Deliverable
1. 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.
2. Validation of computer system integrity to ensure accurate, reliable, consistent, secure deliverables of computer records and signatures against intended performance.
3. Through understanding CSV-V model and its application in machine testing within the Pharma industry.
2. Client Management
1. Attend regular site reviews via Teams or in person at the clients or manufacturers site.
2. Validate process and documentation supplied against requirements and give expert feedback.
3. Ensure Directors are kept up to date with progress.
4. Present monthly client update at company business meetings.
5. Project management of technical deliverables against project plan.
3. Relationship management
1. Develop collaborative relationships that are effective for both the client and for employer.
2. Understand client's values and motivations, ways of working and ordering processes; tailoring your approach to suit their requirements.
3. Encourage and manage performance feedback from the client.
4. Build a rapport with the 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
Desirable
GAMP or equivalent
18th Edition or Plc training
Experience
Siemens and or Rockwell Plc and Scada knowledge
Manufacturing or Pharma background (3 years)
Knowledge of Process Manufacturing Equipment (2 years)
Skills
Automation Design and Commissioning
Ethernet Protocols & data Comms eg OPC comms
Software backup and recovery
Functional Safety and Machine Safety
Design Risk Assessment and CE marking
Hands-on, practical bias, can do attitude
Customer focus and delivery of results
Project Management
About Company:
We are one of the UK's leading manufacturing consultancies and employ engineers, project managers, technologists, and validation specialists. We help define capital investment projects, deliver them and track benefits with certainty. Our engineers install and validate advanced manufacturing technology from around the world.
We are a positive, look-ahead, company. People like to work for us. We invest in training and development. We react swiftly to opportunities, make the most of good ideas, and play to people's strengths.
We have 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. The internet 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 of company 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, everyone employed at the company has 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!
Application Process
If you have the above skills and wish to be considered for this position or find out more details then please submit your CV.
We will endeavour to contact all applicants however if you do not hear from me within two weeks then unfortunately you have been unsuccessful.
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