Validation Specialist

This role will author, execute, and closenvalidation documentation;develop associated procedures;and coordinate activities with Quality, Manufacturing, Quality Control and other stakeholders. Summary The Validation Specialist will support qualification of Climet environmental monitoringninstruments used in cGMP manufacturing suites.

Actual Job Tilte - Validation Specialist
5 days a week Onsite.

Summary The Validation Specialist will support qualification of Climet environmental monitoringninstruments used in cGMP manufacturing suites. This role will author, execute, and closenvalidation documentation;develop associated procedures;and coordinate activities with Quality, Manufacturing, Quality Control and other stakeholders. The individual will independently manage qualification deliverables while ensuring compliance with site procedures and applicable regulatory requirements.

Essential Duties and Responsibilities
Lead qualification activities for Climet environmental monitoring instruments and
related components.
Develop qualification plans, risk assessments, and project timelines.
Author, review, and execute IQ, OQ and PQ protocols.
Prepare qualification summary reports and final closeout documentation.
Draft and revise SOPs, work instructions, forms, and other controlled documents.
Coordinate instrument installation, vendor support, calibration, and maintenance
activities as applicable.
Document, investigate, and support closure of protocol discrepancies, and exceptions.
Work cross-functionally with Quality Control, Quality Assurance, Manufacturing, and
Information Technology.
Ensure qualification records are complete, accurate, inspection-ready, and maintained in
the site document management system.
Track project milestones, communicate status, identify risks, and drive timely completion
of deliverables.

Qualifications
Experience qualifying equipment, instruments, or systems in a pharmaceutical, biotechnology, medical device, or similarly regulated environment.
Hands-on experience authoring and executing IQ, OQ, and/or IOQ protocols.
Strong technical writing skills, including protocols, reports, SOPs, and discrepancies.
Working knowledge of cGMP, Good Documentation Practices, and applicable regulatory
requirements, including 21 CFR.
Familiarity with document management systems and electronic quality systems,
experience with execution of IOQs through Kneat a plus.
Ability to independently manage project deliverables, priorities, timelines, and follow-up
actions.
Ability to work effectively with cross-functional technical and quality teams.
Strong attention to detail, organization, communication, and problem-solving skills.
Proficiency with Microsoft Word, Excel, and Outlook.
Experience with environmental monitoring systems, airborne particle counters, Climet
instruments, cleanrooms, or QC Microbiology is preferred.

Education and/or experience
Bachelor s degree in Engineering, Chemistry, Biology, Microbiology, Biotechnology,
Pharmaceutical Sciences, or a related technical field preferred.
Minimum of 3 years of relevant validation, equipment qualification, Quality Control,
Engineering, Quality Assurance, or technical operations experience in a regulated
manufacturing environment.
Minimum of 2 years of direct experience writing and/or executing qualification protocols
and preparing associated controlled documentation preferred.
Equivalent combinations of education, training, and directly relevant experience may be
considered.

Physical Demand
Ability to perform desk-based documentation work and work in laboratory, manufacturing, and controlled-area environments.
Ability to stand and walk for extended periods during protocol execution and field activities.
Ability to occasionally bend, reach, stoop, push, pull, and move supplies or equipment.
Ability to occasionally lift and carry up to approximately 25 pounds.
Ability to wear required personal protective equipment and cleanroom gowning.
Working
Environment
Work is performed in office, laboratory, and cGMP manufacturing environments.
Entry into controlled areas and cleanrooms may be required;special gowning and
protective equipment may be required.
May work around common laboratory or manufacturing materials, including cleaning
agents, alcohols, and buffers.
Project timelines and manufacturing schedules may require schedule flexibility, including
occasional off-shift or weekend support.