Process Engineer Jobs

About The Position

Requirements

• Strong understanding and hands-on experience in GMP manufacturing or process development of parenteral products, including pharmaceutical or biologic quality attributes and manufacturing controls.
• Working knowledge of risk-based decision-making and stage-appropriate implementation strategies for clinical manufacturing, technology transfers, and commercial manufacturing.
• Ability to work with global and cross-functional teams in dynamic, time-bound environments.
• Ability to build effective working relationships across QA, Project Management, Business Development, and Manufacturing to support introduction of new processes and products.
• Experience with root-cause analysis and product-quality impact assessments for deviations and investigations using Lean and Six Sigma tools.
• Strong problem-solving skills, including identifying issues, providing solutions, and thinking ahead.
• Ability to communicate effectively with internal and external clients about technical feasibility and GMP readiness.
• Bachelor's degree in Engineering or a science-related field and six years of industry experience, or a master's degree and four years of industry experience; equivalent education or experience may substitute.
• At least three years of experience in Fill/Finish or Aseptic Process operations.
• At least three years of experience bringing pharmaceutical equipment, processes, or methods from development to GMP operational readiness.

Nice To Haves

• Experience in clinical or commercial GMP manufacturing.
• Working knowledge of GMP production-related IT systems such as SAP and LIMS.

Responsibilities

• Support technology transfers as a subject matter expert, overseeing transfer of processes and technologies from client process development to GMP manufacturing for new product introduction.
• Contribute to technical evaluation of new processes, technologies, methods, and materials, and facilitate innovation focused on customer needs and GMP products.
• Maintain expertise in pharmaceutical manufacturing technologies used in scale-up, scale-down, and design of experiments (DoE).
• Participate in creating manufacturing procedures and SOPs for new processes and products.
• Own and support process validation studies and data and trend analysis; assess process robustness and capability using statistical analysis to create and monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
• Own deviations, CAPAs, and audit responses; support floor-level troubleshooting and root-cause investigations.
• Develop collaborative relationships with global and site partners and customers, including Validation and Analytical Development.
• Develop potential-client presentations and proposals, including project evaluations and technical feasibility assessments.
• Build scientific knowledge and technical expertise within and beyond the MS&T department.
• Provide technical training and mentorship to junior MS&T members and manufacturing operators.

Benefits

• Medical, dental, and vision coverage
• Flexible Spending and HSA options
• Life insurance
• Short- and long-term disability
• Pet insurance
• Generous PTO, sick, and holiday time off
• 401(k)