Validation Engineer III

ForDoz Pharma Corp

East Windsor, NJ

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JOB DETAILS

SALARY

$80,000–$120,000 Per Year

SKILLS

Asepsis, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Cleanroom, Code of Federal Regulations, Commissioning, Communication Skills, Computer Systems, Control Systems, Corporate Policies, Cross-Functional, Current Good Manufacturing Practice (cGMP), Drug Manufacturing, FDA Requirements, GMP (Good Manufacturing Practices), HVAC, Housekeeping/Cleaning, ICH Regulations, Maintain Compliance, Manufacturing, Multitasking, Oncology, Pharmacy, Presentation/Verbal Skills, Process Manufacturing, Product Development, Project/Program Management, Quality Assurance, Quality Control, Quality Management, Regulations, Reporting Skills, Risk Analysis, Risk Management, Root Cause Analysis, Six Sigma, Standard Operating Procedures (SOP), Status Reports, Sterilization, System Validation, Systems Administration/Management, Team Player, Validation Plan, Water For Injection (WFI), Writing Skills

LOCATION

East Windsor, NJ

POSTED

4 days ago

### Expected Start Date 06/29/2026 ### Compensation $80,000.00 - $120,000.00 / Yearly ### Hours Per Week 40 ### Number Of Positions 1 ### Job Description The Validation Engineer will perform validation activities associated with equipment, processes, facilities, and computer systems to ensure compliance with applicable current Good Manufacturing Practice (GMP) regulations, site Standard Operating Procedures (SOP), and corporate policies. Job Responsibilities · Prepares Risk and Impact Assessments, Protocols and Summary Reports. Coordinates review and approvals of the documents · Schedules, coordinates, and conducts qualification activities (e.g. Installation Qualification, Operational Qualification and Performance Qualification), · Supports 3rd party/vendor qualification activities, if applicable · Work closely with various departments in the design and development of validation protocols · Manages validation projects and prepares status reports · Assist with commissioning, FATs and SATs · Perform periodic review of equipment /systems · Responsible for planning and oversight of onsite cleaning validation programs compliant with FDA requirements · Collaborate with cross functional groups: QC, Operations, Product Development, Facilities, QA. Requirements · Bachelors in chemistry, biology, pharmacy, engineering or other scientific discipline or related field, plus 2+ years validation related experience in commercial pharmaceutical manufacturing · Considerable knowledge of validation processes and procedures. · Computer system validation experience is a plus · Experience and knowledge of HVAC systems, clean rooms, sanitary processing, sterilization equipment, and WFI systems, computer control systems, cleaning processes and aseptic manufacturing · Extensive knowledge in cGMPs, ICH, 21CFR Part 11, and other pharmaceutical regulations · Experience in Quality Systems including deviation management and change control process. · Familiar with Operational Excellence (Six Sigma), Quality by Design, Quality Risk Management, Root Cause Analysis tools. · Able to work efficiently and handle multiple tasks simultaneously · Has excellent communication skills (both oral and written). · Works hard and is a team player **Please note this position is not eligible for employment visa sponsorship now or in the future ForDoz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics. Benefits: 401(k) Dental insurance Health insurance Paid time off Vision insurance ### Place of Work On-site ### Requisition ID 06 ### Job Type Full Time ### Application Email HR@fordozpharma.com

About the Company

ForDoz Pharma Corp

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