Validation Engineer

Validation Engineer
Manufacturing Science & Technology

Would you like to join an award winning organization that is dedicated to saving lives?

In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.

Is that you? If so, we want to learn more about you!

Our Bedford, OH facility is seeking a Validation Engineer who supports all aspects of operations including monitoring equipment design and fabrication, start-up, qualification, troubleshooting and continuous improvement within the operations unit. The Validation Engineer has an integral role in supporting equipment commissioning and qualification, development of cGMP operating procedures, and supports ongoing capabilities of operations. The engineer will qualify operations equipment and validate processes by ensuring current design practices and cGMPs are followed. Additionally, the engineer will support continuous improvement through process optimization, process troubleshooting, training, development of equipment specifications/upgrades, and the implementation of innovative new quality and compliance approaches.

Key Responsibilities

• Performs the development and execution of strategies for engineering studies, qualification and validation activities.
• Lead/Perform/Assists in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), design, installation, operation, and performance qualification of equipment and process; including protocol generation, execution and report generation.
• Act as a subject matter expert for production equipment and processes. Provides technical support for problems and projects related to manufacturing operations, environmental containment, facilities design, personnel and facility safety, and regulatory issues. Develop knowledge of and understand regulatory requirements of FDA, OSHA and other regulatory agencies.
• Basic understanding of change management practices in a regulated, controlled environment.
• Demonstrated ability to read, comprehend and interpret equipment manuals, P&ID’s, mechanical and electrical drawings and PLC logic.
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in cGMP compliance, and establish systems that identify opportunities for improvement and make constructive suggestions for change to improve process effectiveness to heighten quality.
• Conduct root cause analysis and provides technical CAPA review, and prepare any necessary investigational reports to facilitate rapid closure of deviations and ensure actions are taken to prevent recurrence.
• Demonstrated skills in troubleshooting critical process or equipment issues. The individual will primarily be working hands on with the equipment, executing tests and collecting data. Expected to spend time on the shop floor, and be trained in the appropriate gowning. Carry out problem solving on the production floor involving relevant stakeholders.
• Identifies and drives opportunities for improvement, making constructive suggestions to improve process effectiveness, product quality and operating efficiency.
• Able to effectively work in a dynamic environment where coordination with other functional groups is necessary. Must be self-motivated and flexible to learn and respond to changing responsibilities and priorities while meeting high quality requirements within a tight schedule.
• Provides leadership, oversight, coordination, administration, and design input for multiple projects, ensuring that all internal customers and company objectives are met in accordance with established company project management practices and procedures.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Experience and Skills

• Bachelor’s degree in Engineering or related field required
• Minimum 3 years of experience in a pharmaceutical manufacturing environment.
• Availability to travel as required to carry out responsibilities such as design reviews, FAT, etc.
• Hands-on experience with automated equipment
• Demonstrated ability to communicate effectively
• Experience with aseptic processing highly preferred
• Experience with Isolator technology highly preferred
• Experience with change control process and equipment qualification is a must

We offer a competitive compensation and benefits package with an excellent working environment that is safe and engaging. Leaders are dedicated to your success and support professional and personal growth through various development and training opportunities. If you are looking for a rewarding career, Xellia is the organization for you!

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.

Read more about Xellia Pharmaceuticals here