Process Engineer II 503A

The Process Engineer II optimizes aseptic filling and lyophilization processes, ensuring safe medication delivery. This role includes developing recipes, troubleshooting equipment, improving processes, ensuring compliance, supporting validations, and conducting risk assessments.

• Provides technical expertise in aseptic filling and lyophilization, troubleshooting issues, optimizing processes, and developing reliable lyophilization recipes.
• Applies statistical methods to monitor variations, perform root cause analysis, identify trends, and optimize performance to drive continuous improvement.
• Prioritizes and implements process changes based on project needs, supporting change management systems while collaborating with cross-functional teams to optimize manufacturing, ensure compliance, and drive process improvements.
• Performs risk assessments, implements corrective & preventive actions to minimize, and develops process documentation, including standard operating procedures and current Good Manufacturing Practices (cGMP) documents.
• Creates reports, graphs, and charts, and provides technical support to executive leadership team and senior leadership team presentations while performing other duties as assigned.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

• Demonstrates strong attention to detail, excellent communication skills for technical and non-technical audiences, and the ability to develop and review standard operating procedures while effectively troubleshooting processes and conducting root cause analysis.
• Possesses expertise in pharmaceutical processing principles, compliance with cGMP, Food and Drug Administration, United States Pharmacopeia, and International Organization for Standardization standards, along with proficiency in statistical data analysis, Failure Mode Effects Analysis, and Microsoft Office tools (Excel, Word, PowerPoint, Outlook).

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

• Bachelor’s degree in chemical, Mechanical or Biomedical engineering, Pharmaceutical Sciences, or a related field.
• Minimum of 5 years of experience in manufacturing, aseptic filling equipment and processes, such vial washer depyrogenation tunnel, filling machines and lyophilizer in the pharmaceutical industry.

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/