Senior Validation Engineer – GMP & CQV for Tech Transfer

NCBiotech; Durham (NC); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive total rewards

Wellbeing programs

Career development opportunities

Supportive culture

State-of-the-art labs

Values-driven company

Job summary

OXB is seeking a Validation Engineer III for its on-site Engineering Team in Durham, NC. You will execute validation activities for instruments, systems, equipment, utilities and facilities, and lead CQV efforts in a regulated manufacturing environment.

Qualifications include a bachelor’s degree in science or engineering, 5+ years in validation, and strong knowledge of FDA expectations. You will participate in inspections, tech transfers, CAPAs, and continuous improvement initiatives.

Qualifications

• Minimum of bachelor’s degree in science, engineering or related discipline.
• 5+ years of experience in the execution of validation studies in a regulated manufacturing environment.
• Thorough knowledge and understanding of FDA and international health authority expectations.
• Experience in authoring and review/approval of CQV documentation including validation plans, protocols, reports, trace matrices and SOPs

Responsibilities

• Write, execute, summarize and lead validation activities for: Analytical instruments, Computer Systems (as applicable to complex instruments and manufacturing equipment),Equipment, Utilities, and Facilities.
• Development of Validation Plans and Validation Plan Summary Reports.
• Develop, review, and provide guidance on internal validation documents.
• Develop, support, and assess CAPAs, Change Controls, Deviations, Investigations and Risk Management as they pertain to validation.
• Provide technical input to strategy/philosophy for validation activities.
• Represent validation during tech transfer activities.
• Front facing during agency inspections client audits representing the validation function.
• Lead and manage complex validation and technical projects.
• Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations, including being on-call for after-hours remote support.

Skills

Validation execution

CQV documentation

FDA compliance

QA liaison

Education

Bachelor's degree in science/engineering

Job description

OXB is seeking a Validation Engineer III for its on-site Engineering Team in Durham, NC. You will execute validation activities for instruments, systems, equipment, utilities and facilities, and lead CQV efforts in a regulated manufacturing environment.

Qualifications include a bachelor’s degree in science or engineering, 5+ years in validation, and strong knowledge of FDA expectations. You will participate in inspections, tech transfers, CAPAs, and continuous improvement initiatives.