We currently have an exciting opportunity available for a Validation Engineer to join a leading life sciences company based in the West Lothian area. As the Validation Engineer you will be responsible for the support, maintenance and execution the facility Validation Program to ensure that validation processes and procedures are in compliance with ISO9001, ISO13485, 21 CFR 600, IVDD 98/79/EC and other appropriate regulations and standards. This includes site safety requirements and applicable Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Engineer will be varied however the key duties and responsibilities are as follows:
1.Co-ordinate all areas requiring Validation. Write and complete protocols and reports. Ensure compliance with regulatory requirements and departmental and organisational objectives. Assist in completing applications for regulatory approval.
2. Provide guidance and support to all departments/staff as needed regarding validation issues, ensuring compliance with regulatory requirements including, with 21 CFR parts11, 211 and 600, ISO9001, ISO13485 and all other Quality Standards and Validation Regulations and Guidance Documents.
3. Support the maintenance and execution of Validation Master Plans for Site Specific Production departments and Corporate Initiatives. Responsibilities include the execution and completion of process and equipment validations and revalidations in accordance with Validation Master Plans, schedules and Company policy. Complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
4. As assigned, participate in cross functional teams to establish validation strategies and objectives to support Business expansion of facilities and processes, throughout the Corporation. Provide validation guidance and expertise for investigation of failures and participate in CAPA, customer complaints and continuous improvement initiatives
5. Write and maintain procedures relating to the Corporate and local Validation and System. Assist in the preparation and presentation of Validation Reports and Key Performance Indicators to management for review.
6. Support the implementation of Validation Key Performance Indicator(s). Monitor trends, and initiate Continuous Improvement opportunities. Escalate any out-of-norm matters to department management as applicable. Contribute to and assist with Validation training Company wide.
7. Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents.
8. Support the IT department in ensuring compliance with Software and Hardware Validation regulatory requirements.
To be successful in your application to this exciting opportunity as the Validation Engineer we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences related discipline, e.g. Chemistry, Biology or Medical Technology.
2. Significant experience in a drug manufacturing, medical device, or biologics industry in Validation, Quality Assurance or GMP manufacturing. Your previous experience should demonstrate expertise in, cGMP, FDA regulations, SOP development, as well as an understanding of Validation and Data Integrity Principles.
3. You will also require analytical and problem solving skills, including presentation of results into meaningful reports. You will need to demonstrate good communication skills (written and verbal) with the ability to collaborate and present at all levels and functions of the organization.
Key Words: validation | GMP | Quality | Manufacturing | ISO13485 | ISO9001 | 21 CFR part 11 | ICH requirements
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Eve Hegarty
- Phone: 0131 202 9700
- Reference: J5631387
- Posted: 14th June 2019
- Expires: 12th July 2019