Validation Specialist

SUMMARY/OBJECTIVE:

Support validation activities for manufacturing equipment, facilities, utilities, processes, and computerized systems in accordance with cGMP and applicable regulatory requirements. This role is responsible for assisting with the development, execution, review, and maintenance of validation documentation and activities to support compliant and reliable operations. The Validation Specialist will work cross-functionally with Quality, Operations, Engineering, IT, and other departments to support system lifecycle activities, continuous improvement, and inspection readiness. Experience with computerized system validation (CSV) is required.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Supports validation activities associated with manufacturing equipment, utilities, facilities, processes, and computerized systems.
• Assists in the preparation, execution, review, and revision of validation protocols and reports, including IQ, OQ, PQ, and CSV deliverables, as applicable.
• Authors, reviews, and maintains validation documentation such as validation plans, protocols, summary reports, traceability matrices, and risk assessments.
• Participates in validation lifecycle activities for equipment and computerized systems, including requirements review, testing, discrepancy resolution, and final documentation.
• Supports computerized system validation activities, including development of user requirements, risk assessments, test scripts, and validation summary documentation.
• Coordinates with cross-functional teams to support validation project timelines, testing activities, and document completion.
• Assists with execution of equipment qualification activities, including support for FAT/SAT, commissioning, and startup activities, as applicable.
• Supports process validation activities and data collection, trending, and analysis for manufacturing and customer projects.
• Participates in deviation investigations, impact assessments, CAPA, and change control activities related to validation systems and processes.
• Help ensure validation activities are completed accurately, on time, and in accordance with internal procedures and regulatory expectations.
• Supports audit and inspection readiness by maintaining organized, complete, and compliant validation documentation.
• Collaborates with internal stakeholders to support implementation of new systems, equipment, and process improvements.
• Maintains working knowledge of current validation practices, industry guidance, and regulatory requirements relevant to pharmaceutical manufacturing and computerized systems.

QUALIFICATIONS AND EXPERIENCE: Bachelor’s Degree in Engineering, Life Sciences, or a related scientific discipline is required.

Requires 3–5 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments with direct experience supporting validation activities.

Experience with computerized system validation (CSV) is required.

Experience in equipment qualification, process validation, or utility/facility qualification in a cGMP environment is required.

COMPETENCIES/SKILLS:

• Working knowledge of equipment, process, facility, utility, and computerized system validation principles.
• Experience supporting CSV lifecycle activities, including requirements, risk assessment, testing, and documentation.
• Familiarity with cGMP requirements, FDA regulations, data integrity expectations, and applicable industry guidance.
• Ability to author and review validation documents with attention to detail and compliance.
• Understanding of deviation, CAPA, change control, and risk management processes.
• Strong organizational and communication skills with the ability to work effectively across functions.
• Ability to manage multiple assignments and meet timelines in a regulated environment.
• Analytical thinking and problem-solving skills with the ability to identify issues and support practical solutions.
• Proficiency in Microsoft Office applications and ability to work within electronic quality/document management systems.
• Willingness to learn and develop technical expertise across validation disciplines.

SUPERVISORY RESPONSIBILITIES:

• No

SCHEDULE:

• In Office Role: 4 days in office in Cranbury, NJ office; 1-day WFH.

SALARY:

• $80,000 to $100,000

WORK ENVIRONMENT:

• Office Environment (standing and sitting) requires minimal physical exertion.

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
• The employee is occasionally required to sit and reach with hands and arms.
• The employee must be able to lift and/or move up to 50 pounds frequently.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral
• vision, depth perception and ability to adjust focus.

TRAVEL:

• Less than 5% of the time.

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.