Overview

The Validation Specialist performs validation activities primarily to include preparing and executing equipment and CSV protocols and preparing final reports for IQ, OQ and/or PQ of basic cell processing and QC lab equipment. The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Essential Functions and Responsibilities

Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc.
Execute IQ/OQ and /or PQ protocols.
Prepare final reports for executed protocols
Prepare final reports for vendor IQ, OQ and/or PQ protocols.
Review of executed IQ/OQ/PQ protocols and raw data.
Perform periodic review/requalification of validated equipment, systems and cleanrooms
Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met.

Qualifications

Minimum BS/BA in engineering or a related Science discipline and 3-7 years of validation experience.
Good computer skills and Microsoft Office knowledge.
Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc.
Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11.

CDMO experience

Competencies/Candidate Profile

Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary.
Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management.
Must be a dedicated self-starter with a high energy level and able to achieve results.
Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution.
Good time management skills to manage and meet deadlines.
Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment.
Ability to multi-task team is essential.
Flexible and able to adapt to company growth and evolving responsibilities.
Highly organized, detail oriented, and ability to manage multiple priorities.

Supervisory Responsibility

Ability to perform the job under direct or indirect supervision

Working Environment

May occasionally work with pressurized systems. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen.
Must have the ability to work in a team-oriented environment and with clients
Must have the ability to work with specialized equipment
This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
Ability to work in cleanroom environment for a moderate amount of time.
Ability to lift, transfer, or ship validation equipment or related accessories.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, or crouch. The employee is occasionally required to lift and/or move up to 30 pounds.
Must where PPE when appropriate.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.