Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

CSV Engineer

Company: i-Pharm Consulting
Location: South East England
Reference: 9233RS
Closing Date: 20 Oct 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

i-Pharm has partnered with a leading medical devices company to hire a Computerised Systems Validation (CSV) Engineer on a permanent basis, to be based in the South Coast. The main objective of this role is to improve the existing manufacturing process by designing and performing validation activities associated with new installation projects. ...

Requirements:

i-Pharm has partnered with a leading medical devices company to hire a Computerised Systems Validation (CSV) Engineer on a permanent basis, to be based in the South Coast.

The main objective of this role is to improve the existing manufacturing process by designing and performing validation activities associated with new installation projects.

Key responsibilities in this role include authoring, executing and reporting CSV activities within the GMP framework and in compliance with the company’s Global QMS requirements, managing multiple validation projects, liaising with the project team and all associated departments on site relating to the validation objects, and adhering to tight deadlines to ensure that the work is completed in a timely manner.

The ideal candidate for this position will be fully conversant and trained in EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and all associated computerised system validation within the pharmaceutical environment.

ROLE RESPONSIBILITIES (not limited to)
• Leading and executing CSV activities on site
• Running CSV life-cycle activities in conjunction with relevant stakeholders on time
• Coordinating CSV activities and acting as the central point of contact for the site CSV to deliver projects on schedule
• Translating local, corporate and regulatory computerised systems requirements into validation requirements
• Writing computer systems life-cycle documentation, protocols and reports for verification, validation and trial purposes
• Performing risk management on computerised systems, assessing the impact on compliance with EU GMP Annex 11, 21 CFR 11, GAMP 5 and then translating the results into action and implementation plans for execution
• Being a subject matter expert in the area of CSV
• Updating all relevant stakeholders including Validation Manager, QA Manager and QA leaders
• Adhering to Change Control Management System for all changes to existing or implementation of new systems
• Ability to travel as required

EXPERIENCE REQUIRED
• Degree level qualification, preferably in engineering or alternatively in Pharmacy, Chemistry, Microbiology, or similar OR significant equivalent industry experience
• Specific training and education in computerised systems validation and/or their implementation in the pharmaceutical industry is preferable
• Minimum 5 years in computerised systems validation
• Ability to work in multidisciplinary teams at all levels
• Strong understanding of GMP, QA and documentation systems in a pharmaceutical environment (e.g. GAMP 5 implementation, site validation master planning, data integrity framework etc.)
• Experience writing and executing computerised systems validation plans, protocols and reports
• Protocol generation and execution across the full validation life-cycle for both process equipment and automated control systems
• Effective communication skills both written and oral
• Experience leading the CSV on projects

ABOUT i-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY
If you would like to discuss this vacancy further, please call Senior Delivery Consultant Rebecca Sparkes on +44 (0)20 3873 7067, or email rsparkes@i-pharmconsulting.com. If this role is not suitable, Rebecca is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS
CSV / Computerised Systems Validation / Engineer / GMP / Manufacturing / Manufacturing Process / Installation Projects / Validation Activities / Global QMS / GMP Annex 11 / 21 CFR Part 11 / GAMP 5 / Medical Devices / Pharmaceutical / Life-cycle / Medical Products / Quality Assurance / South Coast / West Sussex / United Kingdom / Data Integrity/

Apply for this job: CSV Engineer

Contact Information:

Address:  Head Office
212 New King’s Road London
SW6 4NZ
England
Reasons to work for i-Pharm Consulting
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.