Senior Validation Engineer
3 weeks ago
Harvest Technical Services is seeking a highly skilled Senior Validation Engineer to support validation activities and validation change management system for validated equipment, utilities, and facilities. The ideal candidate will have a strong background in process engineering, validation engineering, or technical services, with a minimum of 2 years of experience in a regulated environment.
Key Responsibilities
• Support the development, execution, and management of timelines for CA/SIA/RTM/DIA/URS activities.
• Track and trend activities, reporting on issues affecting predetermined timelines and problems as needed.
• Coordinate the collection, testing, and analysis of samples and reporting of results required per validation protocol.
• Support the change management system for validated equipment, utilities, and facilities.
• Assist with preparation and review of relevant sections of protocol generations/approvals processes.
• Serve as a representative on cross-functional and multi-site teams.
Requirements
• BS in chemical, biochemical engineering, or related field/experience, with a minimum of 2 years of experience in process engineering, validation engineering, or technical services.
• Strong technical writing skills.
• Cleaning and sterilization qualification experience is a must.
• Experience in the pharma/biotech industry is a plus, with knowledge of cGMPs or equivalent regulations.
• Working knowledge of formulation, filling, inspection, and packaging equipment qualification in a regulated environment.
• Demonstrated understanding of project management skills.
• Ability to work with internal teams, partners, suppliers, and customers.
What We Offer
• Competitive hourly rate, with a hiring range of $39 to $49 per hour.
• Opportunities for professional growth and development in a dynamic and innovative company.
• Collaborative and inclusive work environment, with a focus on operational excellence and industrial engineering skills.
• Professional level written and oral communication skills, with a commitment to fostering an environment that encourages continuous learning.
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