Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.

　　Perform Qualification and Validation activities related to process, equipment, cleaning, utilities and facility. Partners with the Engineering, Maintenance, Manufacturing, and other Quality areas to assure all standards, regulations and guidelines are followed in the manufacture of company products.

　　Interacts with all areas and levels of the company in addition to regulatory agencies, vendors, consultants, and other intended parties.

　　The Sr. Validation Specialist has the objective of maintaining high quality standards for the qualification and validation in compliance with all applicable regulatory requirements. In addition, this position is responsible for the regulatory compliance in validation.

　　Main Responsibilities

　　The Sr. Validation Specialist ensures that qualification and validation of process systems comply with regulatory guidelines and standards.

　　Requires developing strategies and systems to improve process performance.

　　Ability to work in cross-functional teams with focus on deliverables, timelines, and meeting customer expectations and requirements.

　　Exercises judgment within defined procedures and practices to determine appropriate actions, uses rigorous logic and methods to solve difficult problems with effective solutions.

　　Implements corrective actions and coordinates activities in conjunction with the appropriate enabling groups, i.e. engineering, quality, maintenance, operations, etc.

　　Acts as project manager on validation projects. Partners with engineering to deliver projects that meet scope, schedule, and budget while fulfilling the operational needs of the project.

　　Provide guidance and lead the management of validation lifecycle for all equipment, facilities and utilities, including IQ/OQ/PQ, requalification/revalidation.

　　Own, manage, and monitor functional area/manufacturing projects and tasks and drive cross-functional projects to completion (such as capital projects)

　　Responsible for facility, utility and equipment qualification programs.

　　Responsible for cleaning validation program.

　　Support process validation PPQ protocol generation, execution and final reports

　　Collaborate with stakeholders and cross-functional teams to ensure alignment and coordination of validation activities with overall business objectives with clear communication and action.

　　Oversight of external validation resources on projects, including work prioritization and execution.

　　SME for validation projects in Internal and Regulatory inspections.

　　Qualifications

　　B.S. degree required in Chemical or Bio-Chemical Engineering discipline with a minimum of 4-6 years of experience in an engineering role within the pharmaceutical, biotechnology or FDA regulated industry.

　　Must have experience with equipment sanitary design principles and materials of construction used in the biopharmaceutical industry. Should also be knowledgeable with the following: ultrafiltration and other filtration systems, cGMP facility design (cleanrooms, ISO classes, HVAC), utility systems common to the biopharmaceutical industry (e.g., WFI, RO water, compressed gases), clean-in-place (CIP) & (COP) equipment and cleaning cycles, clean room design, TCUs and operating principles. Must be familiar with cGMPs, Good Engineering Practices, as well as FDA and EU regulations. Basic knowledge of programmable logic controllers (PLCs) and instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is required.

　　Experience executing capital projects is preferred.

　　Knowledge of basic leadership principles. Focus is on leading/overseeing defined processes, which may require deep, detailed knowledge. Provide solutions to a wide range of difficult/complex problems which require the regular use of ingenuity, innovation, and creativity. May refer to precedents and policies.

　　Able to gather, analyze and interpret information and identify cause and effect relationships.

　　Able to adapt and respond positively to situations and people to meet changing work unit priorities

　　Kedrion Biopharma offers a number of benefits to qualifying employees, including:

　　- Medical, vision and dental insurance

　　- Life and AD&D insurance

　　- Paid holidays

　　- PTO accrual

　　- and much more!

　　Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

　　Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

　　Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.

　　All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.