Description
Are you a CSV or ASV Engineer interested in working for one of the Irelands leading names in High-Tech Pharmaceutical Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!
Title: CSV or ASV Engineer
Rate: Negotiable
Location: Cork, Ireland
Positions Available: 2 Positions available
Type: Contract (18 Months)
A Fantastic new role has just opened up at one of our leading Cork based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
The proposed start date is 1st October - We need YOU
Responsibilities include:
- Reporting to the automation project lead, this role will support Computer/Automation System Validation (CSV/ASV) and data integrity projects with key focus around customer specification, Validation Master Plan, protocols and reports. This person will provide the company with the technical and validation resource to manage the validation deliverables on selected projects and will coordinate the necessary activities for ensuring the timely closure of validation activities on projects.
- Implementation of policies and procedures to validate/qualify computer systems.
- Plan, coordinates and participate in a compliant validation process for quality information technology systems which requires formal validation documentation (FAT, SAT, IQ, OQ and PQ) under appropriate regulatory requirements and company manufacturing standards.
- Generation of project Validation Master Plans.
- Review and approval of third party generated protocols and reports
- Participate in data integrity risk assessments and/or Design FMEAs.
- Analyze the results of testing and determines the acceptability of results against predetermined criteria.
- Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
- Identify current and anticipated requirements for compliant computerized operations and suggest methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
- Lead process improvement projects to improve the validation of computerized systems.
- Coordinate with other departments or outside contractors/vendors to complete validation tasks.
- Participate in regulatory audits and communicates company's computer validation policies.
- Drive solutions, in conjunction with the appropriate department, to ensure customer related problems/issues are communicated and corrective actions are in place and closed in a timely manner.
- Prepare data/presentations and attend review meetings.
- Compliance to all local site Environmental, Health and Safety regulations
- Compliance to all local site company policies, procedures and corporate policies.
- Perform additional duties at the request of the direct supervisor.
Requirements:
- Science or engineering degree with minimum of 5 years' experience
- Experience in the development, support &, improvement of production systems in a manufacturing environment.
- Demonstrated flexible and innovative approach to work.
- Strong knowledge in data integrity
- Familiar with SDLC based on GAMP 5
- A thorough working knowledge of quality systems such as ISO CFR Part 820/21 CFR Part 11/Annex 11 is essential.
- Good understanding of computer system validation.
If you are interested please do not hesitate to email or call me!