IT Validation Engineer
Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.
We are excited for our next Validation Engineer to join our team!
About the role
We are seeking a Validation Engineer who will play a key role on the structure of the company and will support the monitoring, storage and distribution of goods by ensuring that the computerized systems governing these processes are validated following a risk based approach.
- Responsible for implementing and executing our validation solutions.
- Participate in the development of validation documentation for pharmaceutical equipment, facilities and computerized systems used in GxP environments.
- Participate in writing, reviewing, and in the approval of validated SOPs.
- Perform risk assessments to allow proper classification of systems implementation.
- Create and maintain computerized inventory systems.
- Assist with the development of system requirements to ensure that are testable and comply with applicable regulations (21 CFR Part 11, Annex 11).
- Provide assurance that implemented systems comply with cGMP regulations and guidelines.
- Evaluate proposed changes to validated computer systems and recommend level of validation activities required.
- Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology.
- Develop computer systems validation plans, test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan.
- Ensure that integrity requirements are considered during the implementation and validation of a system.
- Work closely with QA Compliance to ensure appropriate validation of cGMP computer systems.
- Work with the IT team to ensure the correct practices and procedures are in place to ensure data integrity
- Participate in internal and external audits.
- Bachelor’s Degree in Engineering, Sciences, Mathematics, Computer Science or equivalent.
- 2-3 years of demonstrated experience in Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
- General understanding of GMP rules and applicable regulations.
- 21 CFR 11/GAMP 5 experience is highly desired.
- Knowledge of systems such as LIMS, TrackWise, SAP B1 is highly desired.
- General knowledge of laboratory and manufacturing control systems is preferable.
- Experience in a biopharmaceutical company is a plus.
- Fluent in English and Spanish.
- Ability to multi-task and meet deadlines in a fast-paced environment.
- Demonstrated ability to work both independently and in a team environment.
- Demonstrated ability to work well under pressure and meet tight deadlines.
- Demonstrated passion for producing high-quality work.
- Proactive management and positive attitude to change and challenges.
- Good Communication skills. technical writing skills and self-management is a must
- Keen attention to detail.