Validation Engineer
- 2ND Floor, Elgee Building, Magnet Rd, Townparks, Dundalk, Co. Louth, A91 YR9X, Ireland, County Louth (IRL)
- Negotiable
- Permanent
- Start date: 03 Jul 22
- Ref: 5082246
- validation protocols
- gmp
- dq
- cv and pv
Job description
Posted 16 June 2022
Validation Engineer
WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.
They are looking for a Validation Engineer to join their site based in Dundalk.
Essential Duties and Responsibilities:
- Responsible for DQ, IQ, OQ, PQ, CV and PV following validation plans and complying with cGMP.
- Drafting of validation protocols and finalizing of reports.
- Maintain site validation procedures and relevant SOPs for shipping, cleaning and process validation.
Requirements:
- A bachelor's degree in Engineering, Science, or relevant Quality Discipline.
- Minimum 3+ years' experience in a GMP environment as a Validation Engineer.
- Knowledge of 21 CFR 210/211, 21 CFR Part 11 and European regulations associated with the pharmaceutical industry.
- Strong understanding of cGMP, compliance, validation practices including the system life cycle and regulatory expectations.
- Organizational skills for concurrent execution of multiple equipment/instrument, facility and utility qualifications and projects.
- Project management skills are desirable.
- Experience with validation for sterile environments, equipment/instrument, facility and utility.
- Familiar with Shipping Validation, Cleaning Validation and Process Validation.
- Verifies that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved validation plan and protocols.
- Provides information on relevant regulations and internal validation policy with regards to equipment/instrument, facility, utility and process validations.
- Provides assistance and ensures the preparation of validation protocols, design specifications and associated documentation for equipment, systems and processes.
- Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Anna Fitzgerald on +353 (0) 83 859 2624 or send your CV to afitzgerald@berkley-group.co
