DIRECTOR, VALIDATION

The Director of Validation is responsible for overseeing the validation program. This role involves leading and managing validation activities across equipment, facilities, processes, cleaning, computerized systems, and various projects such as new product introductions and facility expansions.

The Validation Director will ensure validation requirements align with current Good Manufacturing Practices (cGMPs), regulatory expectations, and industry best practices while managing budgets and resources to meet objectives within specified timelines.

Additionally, the Director will ensure the validation team is well-trained and equipped to support Good Manufacturing Practice (GMP) manufacturing for sterile injectable products.

The role may include managing independent contributors and supervisors to effectively fulfill the department's responsibilities.

The Director will establish and maintain cross-departmental relationships to effectively support and enhance the overall compliance and profitability of the company.

This position is responsible for determining the direction and prioritization of validation activities and will provide input and guidance during the review and approval of regulated, controlled documents.

These include, but are not limited to, Standard Operating Procedures (SOPs), validation protocols, commissioning protocols, deviations, change controls, work orders, and validation master plans for cleaning, facilities, packaging systems, and computer-related systems at Curia.

Essential Duties and Responsibilities include the following.

• Develop and continuously improve site validation program including equipment, process, cleaning, sterilization and CSV
• Responsible for completing initial qualifications and requalification of facility, equipment, process, cleaning and computer systems
• Responsible for directing and providing quality leadership within the validation department and cross-departmental leadership and direction
• Serve as a resident quality validation expert and approved authority in support of validation, change control, work orders, and other related documents as the quality approver
• Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance
• Responsible for ensuring validated parameters are transferred to routine manufacturing
• Responsible for providing guidance and support for site aseptic process simulations
• Provide compliance direction and leadership to the validation department and company-wide in establishing validation strategies based on industry best practices and regulatory expectations
• Provide validation impact assessments for facility, utility, and equipment changes and input related to product technology transfers to the facility
• Serve as the validation liaison and SME by providing technical reviews on new product opportunities, including new equipment and technology
• Coordinate validation activities with section supervisors to ensure timeliness with minimal disruption to production and facility shutdown schedules
• Direct validation process improvements and goals for Curia using current regulations and demonstrated best practices
• Serve as the validation liaison between the site and customers or regulatory agencies during facility audits / inspections
• Support effective and efficient continuous quality and cost improvement efforts
• Hire, train, and develop staff and conduct performance reviews to assure highly effective, team-oriented contributors to Curia's success
• Read / interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Education and Experience :

• Bachelor's degree in Science or related field of study or equivalent work experience required
• Minimum of ten (10) years of progressively greater responsibilities in the pharmaceutical products / medical devices industry, including validation, regulatory compliance, and quality;

and relevant experience in change control and validation activities

• Minimum of five (5) years in a validation leadership role
• Experience working with third-party contract manufacturing in the Pharmaceutical industry, strongly preferred

Supervisory Responsibilities :

This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures.

This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Other Skills and Abilities :

• Strong leadership and management skills to effectively direct and lead the validation function and staff at the Curia facility
• Proficiency in conducting comprehensive reviews of Standard Operating Procedures (SOPs) and preparing detailed month-end reports
• Expertise in providing quality oversight and approval for validation processes related to utilities, facilities, equipment, and manufacturing processes
• Experience in overseeing facility, utility, and equipment upgrades with a focus on ensuring compliance with quality validation standards
• Ability to review and approve qualification, validation, re-qualification, and re-validation documents, including equipment and manufacturing process protocols, deviations, and final reports
• Strong organizational and coordination skills to effectively prioritize and manage multiple validation activities simultaneously
• Knowledge and experience in developing, updating, and maintaining comprehensive validation master plans for the facility and technical packages for product submissions
• Excellent communication skills for effectively liaising with clients regarding changes to facilities, processes, and procedures
• Analytical abilities to provide management with data and insights aimed at reducing potential regulatory actions and enhancing Curia's productivity
• Thorough understanding of regulatory compliance requirements to keep plant management informed about agency, customer, and internal audit commitments
• Capability to design and deliver training programs on quality systems, particularly those related to validation and current Good Manufacturing Practices (cGMPs)
• Technical expertise in validation processes and cGMPs to serve as an internal consultant within Curia's facility
• Provides guidance, coaching, and mentorship to team members
• Demonstrates business acumen
• Fosters a collaborative and positive work environment
• Champions change
• Coaches and Develops
• 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

Other Qualifications :

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

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.

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.

Curia is an E-Verify employer.

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.