Lead Validation Engineer-Solid Dose
Lead validation Engineer
Alkermes, Inc. is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes has an R&D center and US headquarters in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland, and Wilmington, Ohio. For more information, please visit Alkermes website at www.alkermes.com .
The Lead Validation Engineer is responsible for writing, executing, and reporting validation protocols and other relevant documentation. Other validation lifecycle documentation responsibilities may include User Requirement Specifications (URS), Design Qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), cleaning validation, and process validation in support of the equipment, utilities, facilities, products, and processes. The position also requires the use of Risk Assessment tools and the execution of Formal Challenges (Requalifications) and time-based assessments where appropriate. This person will also have responsibilities in the areas of process engineering and improvement, interfacing with Process Development and Manufacturing.
* The Lead Validation Engineer represents the Validation Department as a leader and contributor during validation projects with site strategic impact. This includes support of new and renovated equipment, facilities, and utilities as well as process and cleaning validations for clinical and commercial scale manufacturing of oral solid and parenteral dosage forms. (60%)
* Perform and lead Risk Assessment exercises in support of validation activities (10%)
* Perform formal challenges and time-based assessments as needed. (10%)
* Collaborate with Process Development to ensure successful process development and technical transfer to Manufacturing. (10%)
* Lead and provide support to manufacturing to ensure testing is executed as intended. (10%)
* Maintain knowledge and comprehensive understanding of relevant pharmaceutical regulations and current interpretations affecting equipment, product, process and cleaning validation. (5%)
* Be a resource to other departments for product and process knowledge. (5%)
Bachelors degree in Engineering or Science Field
* 5 - 8 years relevant experience in pharmaceutical validation area with experience in validation of equipment and facilities for manufacture of oral dosage forms .
* Consistently demonstrated validation proficiency with advanced knowledge of equipment qualification (IQ/OQ/PQ), cleaning and process validation.
* Experienced in current validation trends and processes.
* Trained in risk assessment or risk analysis preferred
* 5% travel - For training purposes or to act as company representative for FAT
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.