Description
Lotus Technical Services is a leading solutions provider offering a complete range of automation and technical services specifically designed to enhance productivity and efficiency, and to maximise the value of our customer's core business. We currently have a vacancy for a Senior Validation Engineer on a temporary until the end of 2011.
The Validation Engineer is a member of the Technical Operations Validation team, playing a key role in the planning and execution of validation activities related to Autoclave qualification. All validation activities are conducted in compliance with US and EU legislation to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget.
Responsibilities
- Conduct validation activities in compliance with US and EU regulations, JSC procedures and EHS requirements.
- Develop validation documentation as required (eg specifications, plans, protocols, procedures).
- Review and approve documents prepared by the validation team, other departments and contractor organizations (eg commissioning test plans, impact assessments, change controls).
- Execute qualification protocols as required.
- Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
- Prepare reports of executed protocols for review by QA.
- Initiate and implement change control activities in accordance with site procedures.
- Track and resolve exceptions during qualification activities.
- Prioritize qualification activities in line with the project schedule.
- Co-ordinate qualification activities with engineering, construction and commissioning activities.
- Co-ordinate qualification activities with contractors and vendors as required.
- Co-ordinate qualification document review and approval.
- Collate and organize qualification files for turnover to QADC.
Skills & Requirements
- A degree qualification in science or engineering.
- The person will have a proven track record in the qualification of autoclaves.
- Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries.
- Ability to apply CGMP regulations and guidelines to all aspects of qualification activities.
Key Competencies Required
- Excellent interpersonal skills
- Ability to operate as part of a team is critical and also the ability to work alone as required
- Customer focus
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem solving skills
- Results and performance driven
- Adaptable and flexible
- Domestic and international travel may be required.
Lotus Technical Services is an Equal Opportunities Employer.