Process & Validation Engineer (100% Travel)

COMPANY DESCRIPTION: A career here is life-enhancing. At reputed company, we reputed company our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with reputed company want to reputed company. We reputed company our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputed company across the globe as a strategic biopharma product development and delivery partner. reputed company was recently honored with reputed company's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to reputed company a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At reputed company, we recognize that reputed company members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions reputed company a meaningful impact. For more information, visit www.Synergbiopharma.com (reputed company is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION OVERVIEW : reputed company is seeking an reputed company Process Engineer to assist with, but not limited to, process engineering, process development, materials & engineering sciences, technology transfer, facilities/utilities/technical services, and manufacturing processes. We are accepting applicants who will be able to travel remotely throughout to client sites in the United States. WORK LOCATION: Travel to client sites will be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.)

• Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.
• reputed company start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE).
• Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements.
• Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of manufacturing processes for compliance with quality and regulatory requirements.
• Provide technical support for the product/process lifecycle and reputed company activities.
• Support client requirements to reputed company or help process or engineering projects at vendors or other third-party contract companies, as needed.
• Provide support for improvement projects regarding processes and systems.
• Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable.
• Provide technical support for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration).
• Analyze and recommend improved technology to increase quality and efficiency.
• Provide technical analysis and support for new or improved process systems.
• Facilitate and schedule meetings with subject matter experts across the organization.
• Ensure compliance with cGMP, regulatory, and industry standards. QUALIFICATIONS AND REQUIREMENTS: To reputed company this job successfully, an individual must be able to reputed company each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential duties. Education:
• Bachelor's degree in Engineering, Bio/Pharma Science, or a reputed company technical field of study. Technical Experience:
• 4-7 years of reputed company engineering and/or technical experience required.
• Experience with cGMP Manufacturing reputed company an FDA-regulated manufacturing company.
• Knowledge of cGxP Quality Systems reputed company an FDA-regulated manufacturing company.
• Knowledge of FDA regulations and guidance or applicable regulatory standards

Apply tot his job Apply To this Job