- A new opportunity has arisen for an experienced Validation/CSV Engineer at our client’s busy pharmaceutical site in Co. Waterford.
- As a Validation Engineer you will be responsible for commissioning, qualification and validation activities complying with Engineering and Validation lifecycle requirements including but not limited to FAT, SAT, DR, IV, OV, IQ, OQ and PQ activities for computer systems, facilities, utilities, equipment, cleaning and sterilization.
- The successful candidate will have a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes on site.
Core Duties and Responsibilities:
- Responsible for qualification and validation activities
- Perform qualification and validation activities in a GMP manner aligning with site standards and industry expectations for a sterile manufacturing facility
- Develop test scripts and execute software tests both automated and manual.
- Develop Validation plans as required for the projects
- Write qualification/validation protocols, execute protocols and author reports. Resolve protocol non-conformances as per site procedures
- Knowledge of site standards and industry practices is a requirement
- Present validation approach and study results to project peers and managers
- Present and defend validation studies during regulatory inspections and internal audit
- Generate deviations, CAPAs, perform investigations and root cause analysis
- Perform change control assessments
- Perform SOP revision, review and approval
- Complete all internal and external training
- Lead, motivate, inspire and fully engage with the project team while delivering to a high level of performance.
- Understand the patient and customer needs and build relationships as required to meet project goals.
Qualifications and Experience:
- Bachelor’s degree in engineering/science and 5 years of relevant experience (e.g., engineering or quality role in a regulated environment, preferably GMP)
- Minimum of 3 years of related CSV industry experience (Pharma/Biotech).
- Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required.
- Strong interpersonal, organizational and technical skills.
- Capability to work both independently and in a team environment.
- Strong leadership, analytical and communication skills are required
- Experience in Commissioning, qualification and Validation
- Excellent written and verbal presentation skills to support interactions with senior leadership and inspectors are required
- Excellent understanding of Software Development Life Cycle (SDLC).
- In depth knowledge of the requirements for Computerised Systems and supporting system design.
- Competent at coaching, oversight & decision making on complex CSV issues and associated support systems.
- Trained as a GMP auditor to support internal GxP audits of computerised systems.
- Preferred Qualifications:
- Familiarity with applicable HPRA, US and EU regulatory requirements
- Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
- Excellent technical writing and verbal communication skills
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio
- Knowledge of Validation Lifecycle Approach
- Must be able to establish strong working relationships with stakeholders and other departments
- Understanding of Validation using risk-based approach
- Demonstrated success working across organizations in highly cross-functional team environment.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.
+353 21 2066178
Please note, we do not require agency assistance with this role.