Job Title: Validation Engineer
Location: Cranbury, NJ
Type: Contract
Start Date: ASAP

Overview:
The Validation Engineer is responsible for the preparation, execution, and reporting of validation deliverables for Oral Solid Dosage manufacturing and packaging facilities. This role coordinates with Production, Quality, Maintenance, and other departments to manage projects, support capacity increases, and drive process improvements. The position includes planning, managing, and executing start-up, commissioning, and validation of new or modified equipment trains, working closely with senior validation engineers to develop cleaning and process validation master plans. The Validation Engineer will author and execute validation protocols—such as Installation, Operational, and Performance Qualifications (IOPQ)and utilities qualifications. All activities will be performed in compliance with cGMP, FDA, and other applicable regulatory standards.

Responsibilities: Perform equipment, facility, and utility qualification and requalification activities to ensure compliance with cGMP and quality requirements. Prepare and execute IQ/OQ/PQ protocols for equipment, facilities, utilities, and related software. Support process and cleaning validation by providing surface area data, qualification parameter ranges, and challenge test criteria. Conduct field execution of validation deliverables, resolve deviations, and author final reports. Maintain validation-related process improvement projects. Author, review, and update SOPs. Generate and update supporting documentation such as P&IDs, material/equipment specifications, and requirement specifications in line with industry standards. Work within cross-functional teams and communicate progress effectively to team members and validation management. Ensure accuracy and currency of process and project documentation. Maintain a safe working environment in accordance with company policy and regulatory requirements. Support third-party validation activities as applicable. Complete assigned validation projects on schedule. Stay current with industry trends through training, seminars, professional reading, and participation in industry organizations. Maintain and update the Validation Master Plan (VMP) and ensure all validation documentation is accurate and complete. Contribute to continuous improvement initiatives by analyzing process data and implementing corrective actions. Perform other duties and special projects as assigned by management. Requirements: Bachelor’s degree in Engineering or a related Science field. Minimum 1–3 years of experience in the pharmaceutical industry. Proficiency in reviewing/writing technical documents, risk assessment reports, deviation/investigation reports, CAPAs, validation protocols (IOQ/PQ), and final reports. Experience in qualification and process validation. Strong understanding of regulatory requirements and validation processes. Strong problem-solving and communication skills. Ability to work both independently and in a team/matrix environment. Strong organizational skills with the ability to manage multiple priorities in a fast-paced setting. Proficiency in Microsoft Word, Excel, Visio, and Minitab. System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
 

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.