Summary:

The Validation Specialist III is a senior-level professional responsible for leading the development, review, and execution of complex validation protocols supporting manufacturing, quality, and regulatory compliance. This role provides advanced technical expertise and strategic guidance on equipment, process, system, and computer system validations in accordance with c

GMP, FDA

regulations, and industry standards such as GAMP. The Validation Specialist III leads cross-functional validation projects, coordinates validation activities across multiple departments, and ensures seamless integration with production and quality timelines. This role authors and approves comprehensive validation master plans, protocols, and technical reports while driving continuous improvement initiatives to optimize validation processes. Additionally, the Validation Specialist III mentors junior validation staff, supports regulatory inspections and audits, manages validation-related investigations and deviations, and collaborates with external vendors and regulatory bodies. This position plays a key role in shaping validation strategies and ensuring organizational readiness for new product introductions and regulatory submissions.

Essential Duties and Responsibilities:

Lead the development, execution, and review of complex validation protocols, including computer system validation, manufacturing equipment qualification, packaging equipment validation, and lyophilizer qualification. Author, maintain, and approve comprehensive validation master plans ensuring full compliance with regulatory requirements and industry standards such as FDA, cGMP, GAMP, and EU GMP Annex 11. Oversee and conduct validation testing activities, analyze data for accuracy, reliability, and compliance, and prepare detailed final reports with recommendations for adjustments or corrective actions. Lead cross-functional collaboration to coordinate and integrate validation activities with production and quality teams, ensuring projects meet timelines with minimal disruption. Provide expert technical guidance and mentorship on new equipment installations, system modifications, and validation best practices to junior and mid-level validation staff. Drive continuous improvement initiatives focused on enhancing validation processes, procedures, and documentation standards. Manage relationships with external vendors and consultants to support validation projects and ensure adherence to quality and compliance standards. Support regulatory inspections and audits by preparing documentation, responding to inquiries, and addressing validation-related observations. Develop and deliver technical training and support to personnel on validation methodologies, regulatory expectations, and quality standards. Participate in special projects and perform additional duties as assigned by management to support departmental goals and organizational objectives. Read/interpret SOPs to ensure compliance Maintain up to date trainings Other duties as assigned

Education and Experience:

Bachelor's degree in Computer Engineering , Physical Sciences, or relevant field of study Minimum of five (5) years validation related work experience Knowledge of regulatory requirements, including FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, and GAMP 4 and 5 based on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance

Supervisory Responsibilities:

This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

Language Skills:

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical Skills:

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Other Skills and Abilities:

Provides guidance and mentorship to team members Fosters a collaborative and positive work environment Champions change Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members. Demonstrates strong attention to detail Proficiency in advanced mathematics (e.g., calculus) and technical writing

Other Qualifications:

Must pass a background check Must pass a drug screen May be required to pass Occupational Health Screening Must obtain and maintain gowning certification May be required to obtain and maintain media qualification

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The essential physical demands will vary for each Curia position. All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background. The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment. The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials. Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection. All environments may be subject to working with or being exposed to cleaning agents. Education, experience, location and tenure may be considered along with internal equity when job offers are extended. We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral. All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 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Validation Specialist III