Validation Engineer - Billerica, MA

Organisation Description
EMD Serono, Inc. is a leader in US biotechnology, focusing on reproductive health, metabolic endocrinology, and neurology. More than 500 people work in the world-class facilities in Rockland, MA, and approximately 250 work in the field.
Description

PURPOSE OF THE ROLEResponsible for all validation activities required to maintain cGMP compliance producing Phase 0, I, II clinical material in the Protein Production Laboratory (PPL).KEY TASKS & RESPONSIBILITIESFunction as the primary resource for PPL Validation activities related to maintaining cGMP validation compliance. Develop and lead the execution of validation activities in the PPL. Author, update and review validation documentation.Perform the validation of equipment and systems Interact with all disciplines, internal and external, to schedule all validation activities and apply resources to insure completion of company goals. Possess a thorough knowledge of the cGMP aspects of pilot plant operations and the ability to translate this into Validation activitiesPotential management outside validation contractors Maintains all validation documentation. May provide engineering support all aspects of the PPL operation including, equipment design and specification for cell culture, purification, utilities, BMS, validation, QC, etc.... May provide engineering support and expertise for the implementation of process optimization efforts.Cleaning verification and validation experience May assist the manufacturing operation in problem solving with regards to equipment and systems. Change controls assessment for re-validation requirements
EDUCATION & LANGUAGESRequires a Bachelors/Masters degree in science or engineering related field. Skilled in the knowledge and use of all Validation related equipmentPROFESSIONAL SKILLS & EXPERIENCE4-6 years experience in validation in the biotech/pharmaceutical industryDemonstrated success applying validation principles to the execution of validation activities Demonstrated success in consistently executing validation activities Possess a thorough knowledge of cGMP's, CIP and SIP.PERSONAL SKILLS & COMPETENCIESPossess excellent oral and written communication skills.Strong teamwork and decision making skills.Ability to function in a rapidly changing environment and balance multiple priorities simultaneously. Pharmaceutical process or research product development experience preferred. ADA REQUIREMENTSNot Applicable - Position required to work in processing clean room environment and requires specific level of physical activityPosition will require both occasional domestic and international travel up 5-10% of timeCORE PILLARS COMPETENCIES Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instruction on new assignments.Can be relied on to demonstrate the core Merck Serono Values