Process Engineer MSAT in Paulsboro

Energy Jobline ZR; Paulsboro (NJ); On-site; USD 80,000 - 95,000; Full time

Job summary

Specialty Chemical Company in Paulsboro, NJ is seeking a MSAT Process Engineer to join its production team onsite. You will evaluate, design, and implement processes as development transfers to production, monitor operations for safety and quality, and lead continuous improvement in yields and efficiency.

You will collaborate with cross-functional teams and customers, support tech transfers, scale-up, validation, and documentation. FDA/cGMP knowledge and strong analytical skills are essential.

Qualifications

• B.S. in Chemical Engineering or equivalent.
• Minimum of 3 years of manufacturing or process engineering experience in pharmaceuticals or batch processing.
• Gives safe, compliant process development and tech transfer.
• Ability to interface with internal and external clients.
• Knowledge of FDA/cGMP guidelines.
• Strong analytical and problem-solving skills.

Responsibilities

• Evaluate, design, and implement new or improved processes during transfer from development to production.
• Monitor manufacturing processes and provide production support.
• Troubleshoot process issues and lead tech transfers.
• Collaborate with cross-functional teams and customers to implement safe, efficient processes.
• Support scale-up and validation runs, including cleaning and process validation.
• Lead or support cross-functional teams for new tech introduction.
• Prepare batch records and technical reports.

Skills

Process engineering

FMEA

Root cause analysis

Statistical analysis

FDA/cGMP knowledge

Independent work

Client interfacing

Education

B.S. in Chemical Engineering

Job description

Job DescriptionJob Description

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 is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to , , , (including , childbirth, or related medical conditions), , , , , , family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.