MALLINCKRODT ENTERPRISES, LLC Sr. Validation Engineer in Saint Louis, Missouri
JOB DESCRIPTION Company has announced its intent to spin off its Specialty Generics business by the second half of 2019. The spin-off, if completed, will result in the independent company assuming the Company name, and it will be traded on the New York Stock Exchange, with its headquarters in the St. Louis, Mo., area. The name Company and its historical values of quality, integrity and service have long been associated with the Specialty Generics business St. Louis heritage. With approximately 1,600 employees globally, the newly spun company will include an acetaminophen business footprint., a portfolio of both active pharmaceutical ingredients and generic finished dose forms of controlled substances and other drugs, a niche specialty generics development portfolio, a portfolio of third-party promoted and non-promoted branded drugs, and a strong U.S. manufacturing JOB DESCRIPTION The Sr. Validation Engineer will create, review and/or execute primary validation activities for equipment, utilities, computer systems and manufacturing processes. The overall objective of the position is to ensure product quality and site compliance to FDA requirements. Interfaces with manufacturing, quality assurance, engineering and RandD to obtain the process, equipment, controls, and installation support documents necessary for protocol development and review. ESSENTIAL FUNCTIONS/SKILLS: * Development and execution of validation documents including but not limited to: SIA, CIA, FAT, SAT, CV, IQ, OQ, PQ, PV, FSR * Performs validation document review and approval * Responsible for validation procedure and template creation and improvement * Writes validation deviation investigation * Develops validation plans * Provides audit support customer/regulatory /corporate, etc. as needed * Responsible for document management including scanning and archival of validation documents DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: MINIMUM REQUIREMENTS: Education: BS preferable with related technical background. Experience: Minimum of 7 years experience in pharmaceutical validation performing qualifications in a pharmaceutical manufacturing environment. Proven personnel and project management history. Complete knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11 and Data Integrity requirements. Knowledge of ICH Q7 and Q11 preferred. Preferred Skills/Qualifications: * Excellent written and oral communication and leadership skills. * Ability to lead and influence people. * Ability to work in and promote a team environment. * Working knowledge of Six Sigma and/or Lean manufacturing tools. * Complete understanding and application of principles, concepts, practices, and standards within discipline. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position..Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Employer's Job# JR000009630Please visit job URL for more information about this opening and to view EOE statement.