Validation Specialist – Biotech Downstream Process Equipment jobs in United States
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Mentor Technical Group · 4 months ago

Validation Specialist – Biotech Downstream Process Equipment

positionUnited States
timeFull-time
remoteRemote
seniorityMid Level
date3+ years exp

Mentor Technical Group (MTG) is a world leader in life science engineering and technical solutions, providing support for the FDA-regulated industry. They are seeking a Validation Specialist to develop and execute validation protocols for downstream process equipment, collaborate with various teams to ensure compliance, and support regulatory inspections and audits.

BiotechnologyFacility ManagementLife Science
badNo H1BnoteU.S. Citizen Onlynote

Responsibilities

Develop, review, and execute validation protocols (IQ, OQ, PQ) for downstream process equipment
Perform risk assessments, gap analyses, and validation reports for new and existing equipment
Collaborate with engineering, QA, and operations teams to ensure equipment meets regulatory requirements
Support commissioning and qualification activities for bioprocess systems, including filtration, chromatography, and centrifugation equipment
Review and approve validation documentation, SOPs, and change controls
Identify and implement continuous improvement initiatives in validation processes
Support regulatory inspections and audits, providing required validation documentation

Qualification

Validation protocolsCGMP knowledgeFDA guidelinesIQ/OQ/PQ experienceDownstream processesComputerized systems validationProblem-solving skillsCommunication skillsOrganizational skills

Required

Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, or related field
Minimum 3–5 years of experience in validation of biotech downstream process equipment
Strong knowledge of cGMP, FDA, and ICH guidelines
Experience with IQ/OQ/PQ protocols and validation documentation
Familiarity with downstream processes such as chromatography, filtration, and centrifugation
Excellent problem-solving, communication, and organizational skills

Preferred

Advanced degree in relevant scientific field
Experience in a multi-site or global biotech environment
Knowledge of computerized systems validation (CSV) and automated process control systems

Company

Mentor Technical Group

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Mentor Technical Group is a minority-owned business setting new standards for multidisciplinary compliance, technical, and engineering services.
dateFounded in 2000
location
Caguas, NA - Puerto Rico, PRI
people-size501-1000 employees
web-link
https://www.mentortg.com

Funding

Current Stage
Late Stage

Leadership Team

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Lydmarie Llorens
HR Business Partner and Compliance Manager
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Neyshia Rivera, MA
Human Resources Business Partner
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