Process Validation Jobs in New Jersey (NOW HIRING)

Job Title: Process Engineer MSAT Location: Paulsboro, NJ Compensation: $80,000-$95,000 Work Model: Onsite – onsite

Overview Specialty Chemical Company is seeking a MSAT Process Engineer to join their team in Paulsboro, NJ!

Responsibilities

• The Process Engineer I, MS&T is responsible for the evaluation, design, and implementation of new or improved processes as they are transferred from development to production.
• Monitoring manufacturing processes, providing production support, and ensuring compliance with safety and quality standards.
• Troubleshooting processing problems, technology transfer of existing processing into or out of the New England sites, and other production-related duties in support of the business unit.
• Collaborating with cross-functional teams and external customers to implement safe, efficient, practical, and commercially viable processes that generate consistent, high-quality API supply.
• Monitoring ongoing manufacturing operations to ensure safety, quality, and yield objectives, including Annual Product Reviews, are met.
• Evaluating new product proposals and leading new product introduction.
• Leading process improvement efforts to improve yields, reduce costs, and enhance overall efficiency.
• Supporting the design of scale-up and validation runs in the manufacturing plant, including cleaning validation and process validation.
• Collaborating with Project/Facilities Engineering on capital projects (URSs, PFDs, M&E balances, PHAs, design reviews, commissioning, and start-up).
• Leading troubleshooting efforts using root cause analysis for process and equipment issues.
• Writing and reviewing Batch Records, Process Safety Information, validation protocols, operator training materials, and technical reports.
• Developing process performance tracking procedures and analyzing data for optimization opportunities.
• Leading or supporting a cross-functional team in the introduction and optimization of new processes/equipment related to the introduction of new technologies/product or internally driven operational improvements.
• Communicating, interacting, and working closely with external customers, technical support personnel, Quality Control, Quality Assurance, and plant operators.
• Supporting the implementation of new equipment in the plant and assisting with continuous improvement initiatives.
• Writing high-quality reports and delivering presentations to customers and management in a timely manner aligned with project milestones.

Requirements

• B.S. in Chemical Engineering or equivalent technical degree.
• Minimum of 3 years of manufacturing or process engineering experience in pharmaceuticals or batch processing.
• Able to successfully interface with internal and external clients.
• Strong understanding of chemical operations.
• Demonstrates good judgment, quick decision-making skills, and the ability to work independently.
• Knowledge of FDA/cGMP guidelines and practices.
• Statistical analysis skills.
• Failure Mode and Effect Analysis (FMEA) and root cause analysis skills.

System One, and its subsidiaries including Joulé 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.

#M-3 #LI-GS1 Ref: #558-Scientific