Senior Process Engineer, Sterile

Description:

The Senior Process Engineer in sterile manufacturing will ensure the compliant, efficient, and safe transfer of new products, implementing manufacturing processes from concept to launch, including scaling up and aseptic process simulation. The position will lead continuous improvement initiatives and support process discrepancies. The role serves as Subject Matter Expert (SME) for providing technical expertise for sterile/aseptic, filling and packaging technologies, formulation, Lyophilization, depyrogenation and root cause analysis.

Essential Functions:

• Develop, author, and execute protocols to ensure compliance with FDA and cGMP requirements, including process validation, cleaning validation, and automated system and control qualification. Monitor, interpret, and analyze manufacturing data to support the full process lifecycle, identifying opportunities for improvement and facilitating investigations to resolve process deviations and anomalies.
• Develop and manage technical plans, project scopes, design suitability studies, and implementation schedules to establish manufacturing process capability and support the introduction of new or reformulated products. Conduct feasibility assessments, risk analyses, budgeting, and project execution in alignment with business objectives. Collaborate closely with R&D and Manufacturing teams to transition processes from development to scale‑up and full commercial production. Evaluate and implement new technologies to strengthen and expand manufacturing capabilities.
• Provide real‑time troubleshooting for complex manufacturing equipment failures and process deviations, ensuring prompt resolution to maintain operational continuity. Lead personnel training, develop manufacturing instructions, and support the start‑up of new processes and equipment. Monitor key performance indicators—including quality, yield, throughput, cycle time, and critical process parameters—to drive improvements and ensure compliance with cGMP, safety, and environmental requirements. Collaborate with vendors and suppliers to define system requirements and validate functional specifications for sterilization, decontamination, and environmental control systems.
• Serve as a Subject Matter Expert (SME) by providing advanced technical expertise across key manufacturing processes, including chemical and biological formulation, filling, packaging, and contamination‑control operations. Develop and revise SOPs, ensuring alignment with regulatory and operational requirements. Lead and manage change controls and conduct impact assessments to support compliant process modifications. Support and lead investigations to determine root causes, perform data analysis, and drive effective CAPA implementation. Contribute to the creation and revision of process documentation and batch records to ensure accuracy, compliance, and continuous improvement.

Additional Responsibilities:

• Verify and develop P&ID, engineering layout, engineering drawings and engineering documents.

• Employ key project management principles including establishing and tracking timelines, identifying and mitigating risks, and communicating across teams at all levels.

   

Education:

• Bachelors Degree (BA/BS) Engineering, manufacturing or related field - Required
• Master Degree (MS/MA) Engineering, manufacturing or related field - Preferred

Experience:

• 5 years or more in Experience in engineering roles within a GMP manufacturing environment/Life science with sterile/aseptic facility.

Specialized Knowledge:

• Strong understanding of cGMP, FDA regulations, and other relevant standards.
• Proven project management and leadership skills.
• Exceptional problem-solving and decision-making abilities.
• Strong communication and interpersonal skills to facilitate collaboration across teams.
• Proficiency in relevant engineering software and tools.

Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.

The base salary for this position ranges from $110,000 to $125,000 per year.   Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting.  Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.  At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.  We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.