Vacancy caducado!
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.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.The Associate Validation Specialist at Kedrion provides technical input to Kedrion’s plasma fractionation & parenteral products process design, commercialization, and aseptic manufacturing science advancement. This role is crucial for Kedrion’s success and it will be a key contributor to Kedrion’s drug product and process development, commercialization, and life cycle management of the product portfolio.As a key contributor to Kedrion’s commercialization development and aseptic process introduction into clinical and commercial facilities, the Associate Validation Specialist must integrate and successfully utilize knowledge and information generated by cross functional teams involved in product, process, delivery systems, packaging, and equipment (engineering, analytical, quality, regulatory, clinical and commercial manufacturing) to positively influence Kedrion practices and ensure success through the commercialization lifecycle.Supports Sr. Validation Specialist on process improvement projects. Works hand-in-hand with the other Validation Specialists to support and perform Qualification and Validation activities related to process, cleaning, equipment. 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 Associate Validation Specialist has the objective of maintaining high quality standards for the qualification and validation in compliance with all applicable regulatory requirements.Main Responsibilities
Conduct Periodic Reviews and remediation of gaps discovered during Periodic Reviews.
Assists in the design, execution and documentation of validation/qualification documents related to the cleaning, equipment, utilities, and software associated with the development of drug product.
Helps to drive best practices and technical advancements across Kedrion network and will be utilized for their knowledge and expertise of areas as they develop.
Participates in global cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
May travel domestically up to 10% of the time
Background and Experience
B.S. in Biomedical Engineering, Bioprocessing, Chemical Engineering or Biological Sciences preferred or documented experience in a validation role for at least 3 years.
Aseptic fill and finish experience are preferred.
Multi-parametric downstream purification processes and TFF/DF a preferred
Qualifications:
A strong knowledge of biological processes, equipment, utilities, and knowledge of software validation/qualification principals and lifecycle documentation [NC1] a plus.
Must possess a strong understanding of all Science/Engineering principles applicable to Biopharmaceutical and Pharmaceutical Development/Manufacturing.
Experience in Biopharmaceutical Manufacturing or Process/Technology Development in a technical role. Basic knowledge about pathogen safety studies is preferred.
Good written and oral communication skills a must.
Basic knowledge around project planning and prioritization preferred.
Logical and independent thinking.
Passionate personality and positive attitude.
Prior experience in FMEA is a plus
Sound understanding and demonstrated application of statistical methods/ tools [NC2] a plus
In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements [NC3] a plus
Excellent interpersonal skills
Multi-tasking abilities
Outstanding organizational skills
Ability to operate in a fast-paced, multi-disciplinary industrial environment
Vacancy caducado!