Validation specialist

Innova Solutions is immediately hiring a Validation Specialist

Job Title : Validation Specialist

Position type : Full-time Contract

Duration : 12 Months

Location : Warren, NJ Onsite

This role supports the successful operation of facilities, laboratories, and business functions at multi?use sites through interaction with internal team members and peer?

level customers as well as external service providers. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Facilities and Utilities commissioning and qualification and ongoing work activities of low to moderate complexity, individually and with support of others.

The incumbent spends most of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.

The incumbent in this role works with entry, junior, and experienced level professionals to accomplish daily tasks and short?

term projects according to established policies and procedures.

Required Competencies Knowledge, Skills, and Abilities :

• Intermediate knowledge of cGMP pertaining pharmaceutical facilities, utilities, and equipment.
• Intermediate knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical

manufacturing.

REQUIRED : Intermediate knowledge of commissioning and qualification of clean manufacturing facilities,

material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems.

PREFERRED : Commissioning and qualification of liquid nitrogen supply systems, DI Water, autoclaves, isolators,

filling and capping equipment, and airflow visualization studies.

• Understanding of scheduling and execution fundamentals.
• High proficiency in Microsoft Office Suite Word, Excel, PowerPoint and Outlook. Innate ability to learn new

software, such as corporate intranet and enterprise business.

Working knowledge of scheduling software and systems, and inventory management systems.

Commissioning and Qualification :

a. Administer change control activities and corrective and preventive actions.

b. Review, approve, and execute test protocols, validation deliverables, and plans as needed.

c. Author, review, and approve SOPs, work practices, and other procedural documents.

d. Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.

e. Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.

Promotes and provides excellent customer service and support :

a. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.

b. Provides technical support and guidance on equipment commissioning and qualification. Interfaces with

customers to ensure all expectations are met.

c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification

department and site customers while promoting a positive team environment.

Communication and Management of Timelines :

a. Ensures timely completion of equipment commissioning and qualification projects, individually and / or with

support of contracted personnel.

b. Develops an effective mechanism for communicating the current status of all manufacturing and laboratory

equipment to affected stakeholders.

c. Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.

Regulatory Responsibilities :

a. Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other

Client standards and regulations.

b. Acts as equipment commissioning and qualification SME in internal and regulatory audits.

Education and Experience :

BS in Engineering required. Must be able to read and understand construction and mechanical drawings and

P&IDs.

• Minimum of 3 years of experience in FDA-regulated industry.
• Minimum of 3 years of experience developing and execution facility and utility qualification.
• Strong background and experience in laboratory and manufacturing operations.
• Knowledge of cGMP in the pharmaceutical industry.
• Thorough knowledge and hands-on experience with airflow visualization (smoke studies).
• Strong computer skills, knowledge of calibration management and environmental monitoring systems preferred.
• Experience interacting with external and / or internal auditors in a compliance audit environment with direct

interaction including face to face interaction and response to audit questions is preferred..

Thank you!

Sara Almas

Team Recruitment

PAY RANGE AND BENEFITS :

Pay range : $ $48.00 -$51.00 Per Hour.

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits : Innova Solutions offers benefits( based on eligibility) that include the following : Medical & pharmacy coverage, Dental / vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

Last updated : 2024-05-29

Salary : $48 - $51