What are the responsibilities and job description for the Validation Engineer position at Trinity Consultants?
Validation Engineer
Location : Portsmouth, NH
Join ADVENT Engineering, a leading engineering and consulting firm dedicated to the pharmaceutical and biotechnology sectors. With our headquarters near San Francisco and operations throughout the Eastern and Western US, Canada, and Singapore, we are positioned at the forefront of global pharmaceutical and biotechnology facility design, process engineering, and quality system projects.
At ADVENT, we specialize in process engineering, automation engineering, project engineering, facility design, start-up and commissioning, as well as validation and compliance consulting for prominent biotechnology and pharmaceutical manufacturing companies.
As a key member of our engineering team, you will collaborate with experts in the field to design, automate, commission, and start various processes, systems, and facilities. We are looking for candidates with a blend of strong technical aptitude, automation engineering skills, and proficiency in technical writing.
Responsibilities :
- Develop and implement Quality System documentation to ensure effective validation practices within the organization.
- Create user requirement specifications (URS), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols, executing them in alignment with Good Documentation Practices (GDP) and internal quality standards.
- Design comprehensive validation strategies backed by suitable statistical analyses; perform and coordinate validation activities, review and compile results, and draft validation reports.
- Conduct Data Integrity Assessments and evaluate systems for compliance with 21 CFR Part 11 regulations.
- Collaborate on user and functional requirements for current and upcoming processing equipment, drafting necessary documentation and interfacing with manufacturers to ensure compliance.
- Support cross-functional teams, including R&D and Manufacturing, to facilitate successful technology transfer and continuous improvement initiatives.
- Manage assigned tasks efficiently, proactively communicating any delays or issues to the validation manager and relevant stakeholders.
- Review DeltaV software and specifications to design robust test protocols.
- Adhere strictly to all regulatory, corporate, and Quality System policies.
Qualifications :
