Job Title: Commissioning/Qualification Validation Specialist 
Location: Warren, NJ- Local candidates only 
Hours/Schedule: Mon - Fri, Business Hours
Type: Contract
 
Overview
Leading Pharmaceutical company looking for an experienced Validation Engineer. Ideal candidates should have a minimum of 3 years of experience developing and executing facility and utility qualification. 
 
Responsibilities

• Commissioning and Qualification:
  • Administer change control activities and corrective and preventive actions.
  • Review, approve, and execute test protocols, validation deliverables, and plans as needed.
  • Author, review, and approve SOPs, work practices, and other procedural documents.
  • Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
  • Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.

• Promotes and provides excellent customer service and support:
  • Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
  • Provides technical support and guidance on equipment commissioning and qualification. Interfaces with customers to ensure all expectations are met.
  • 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:
  • Ensures timely completion of equipment commissioning and qualification projects, individually and/or with support of contracted personnel.
  • Develops an effective mechanism for communicating the current status of all manufacturing and laboratory equipment to affected stakeholders.
  • Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.

• Regulatory Responsibilities:
  • Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other BMS standards and regulations.
  • Acts as equipment commissioning and qualification SME in internal and regulatory audits.

• 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 in commissioning and qualification of manufacturing facilities: REQUIRED – manufacturing rooms, material path-throughs;
• Thorough knowledge and hands-on experience in commissioning and qualification of common utilities: REQUIRED – compressed air, carbon dioxide, process air, AHUs; PREFERRED - liquid nitrogen supply systems, DI Water.
• 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.

• AHU commissioning and qualification
• Airflow visualization (smoke studies)     
• CO2 and Process Air systems qualification            
• Facilities commissioning and qualification

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, 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.