PROCESS ENGINEER II

PRIMARY PURPOSE

Provide technical and process engineering support for pharmaceutical and OTC manufacturing operations throughout the product lifecycle, including process development, scale-up, technology transfer, process validation, commercial manufacturing support, equipment qualification, and continuous improvement initiatives. This position serves as a key technical resource for manufacturing operations and requires demonstrated experience operating within a cGMP-regulated pharmaceutical manufacturing environment.

MAJOR DUTIES AND RESPONSIBILITIES

• Provide day-to-day technical support for pharmaceutical and OTC manufacturing operations to ensure safe, compliant, and efficient production.
• Lead and support technical investigations related to manufacturing deviations, non-conformances, out-of-specification results, customer complaints, and process excursions. Develop scientifically sound conclusions and recommendations.
• Author and support closure of deviations, CAPAs, change controls, and technical reports in accordance with site quality systems and regulatory requirements.
• Lead or support technology transfer activities from R&D, pilot plant, or external manufacturing sites into commercial production. Conduct laboratory evaluations, engineering studies, scale-up assessments, and process risk analyses.
• Collaborate with cross-functional teams to develop manufacturing strategies and ensure the successful transfer and commercialization of new products.
• Design, optimize, and implement manufacturing processes and equipment for pharmaceutical, OTC, topical, liquid, semi-solid, and aerosol products from pilot scale through commercial production.
• Support process validation activities including protocol development, execution, data analysis, statistical evaluation, and report generation in accordance with FDA, cGMP, and company requirements.
• Author and execute equipment qualification protocols (IQ/OQ/PQ), commissioning activities, and engineering studies to support new and existing manufacturing systems.
• Develop User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and technical justifications for new equipment, process improvements, and capital projects.
• Participate in equipment selection, installation, startup, and qualification activities associated with manufacturing and facility upgrades.
• Utilize Lean Manufacturing, Six Sigma, and Operational Excellence methodologies to identify and implement process improvements that improve product quality, increase throughput, reduce waste, and enhance manufacturing efficiency.
• Perform process capability analyses, trend evaluations, and statistical assessments to support data-driven decision-making and continuous improvement initiatives.
• Support manufacturing readiness activities for new product introductions and process changes.
• Author, review, and revise SOPs, batch records, validation protocols, technical reports, and engineering documentation required to support cGMP manufacturing operations.
• Maintain expertise in FDA regulations, cGMP requirements, ICH guidelines, and industry best practices related to pharmaceutical manufacturing and validation.
• Support internal audits, regulatory inspections, and customer audits by providing technical expertise, documentation, and responses to observations.
• Participate in quality risk management activities utilizing tools such as FMEA, risk assessments, and control strategies.
• Serve as a subject matter expert (SME) for assigned manufacturing processes, equipment, and product families.
• Make independent technical decisions within assigned projects and responsibilities that impact manufacturing performance, product quality, and regulatory compliance.
• Collaborate effectively with Quality Assurance, Manufacturing, Validation, Regulatory Affairs, Engineering, Maintenance, Supply Chain, and Research & Development teams.
• Support capital projects from concept through implementation, including scope development, vendor interactions, commissioning, qualification, and project execution.
• Perform other duties as assigned to support business objectives and pharmaceutical manufacturing operations.

QUALIFICATIONS

Required

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or related engineering discipline.
• Minimum of 5 years of engineering experience within pharmaceutical, OTC drug, biotechnology, medical device, personal care, or other FDA-regulated manufacturing environments.
• Demonstrated experience working in a cGMP-regulated manufacturing environment.
• Experience supporting process validation, equipment qualification (IQ/OQ/PQ), technology transfer, process troubleshooting, and commercial manufacturing operations.
• Working knowledge of FDA regulations, cGMP requirements, pharmaceutical quality systems, change control processes, deviation investigations, and CAPA systems.
• Strong technical writing and documentation skills.
• Ability to lift up to 40 pounds and work within a manufacturing environment.

Preferred

• 7+ years of pharmaceutical manufacturing experience.
• Experience with topical drug products, semi-solids, liquids, aerosols, combination products, or other complex dosage forms.
• Experience supporting FDA inspections, regulatory audits, and customer audits.
• Lean Six Sigma Green Belt, Black Belt, or equivalent continuous improvement certification.
• Experience with process scale-up and commercial product launch activities.
• Experience with Process Analytical Technology (PAT), statistical process control, and process monitoring systems.
• Master's degree in Chemical Engineering, Pharmaceutical Sciences, or related discipline.

CRITICAL SKILLS AND ABILITIES

• Strong technical expertise in pharmaceutical manufacturing processes, process validation, technology transfer, and regulatory compliance.
• Strong understanding of FDA regulations, cGMP requirements, pharmaceutical quality systems, and validation principles.
• Demonstrated problem-solving and root cause investigation skills.
• Ability to evaluate complex technical data and translate findings into practical manufacturing solutions.
• Excellent written, verbal, and presentation communication skills.
• Strong project management and organizational skills with the ability to manage multiple priorities simultaneously.
• Ability to influence technical and operational decisions through effective collaboration and leadership.
• Strong understanding of pharmaceutical quality systems, validation principles, and quality risk management methodologies.
• Ability to work independently while maintaining strong cross-functional partnerships.
• Demonstrated attention to detail and commitment to data integrity and compliance.
• Ability to wear required personal protective equipment, including respirators, gloves, safety glasses, and other safety equipment as required.
• Ability to work flexible schedules, including evenings and weekends, when business needs require.

COMPUTER SKILLS

• Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
• Experience with ERP, MES, electronic quality management systems (eQMS), document management systems, and statistical software preferred.
• Ability to analyze and trend manufacturing data using spreadsheets, databases, and statistical tools.

TECHNICAL SKILLS AND EXPERIENCE

• Experience supporting pharmaceutical process development, technology transfer, scale-up, and commercial manufacturing.
• Knowledge of process validation lifecycle concepts and equipment qualification requirements.
• Experience with root cause analysis methodologies and quality risk management tools.
• Strong data analysis and statistical evaluation skills, including Statistical Process Control (SPC).
• Experience utilizing FMEA, risk assessments, and process capability analysis.
• Familiarity with Process Analytical Technology (PAT) and continued process verification principles preferred.
• Experience supporting capital projects and equipment implementation activities preferred.

EDUCATION AND/OR TRAINING

• Bachelor's degree in Engineering required.
• Master's degree preferred.

PHYSICAL DEMANDS

• Must be able to lift and maneuver up to 40 pounds.
• Must be capable of standing, walking, and working within manufacturing environments for extended periods.
• Must be able to wear personal protective equipment, including respirators, gloves, hearing protection, and safety glasses, as required.
• Must be able to access manufacturing, warehouse, and utility areas safely and effectively.