Senior Specialist, MS&T Validation

Job Description The Senior Specialist, MS&T Validation provides process validation support to the Devens Cell Therapy Facility (CTF).The Senior Specialist participates in facility, process, and aseptic validation activities, including support of the Aseptic Process Simulation Program and implementation of process lifecycle management changes.Responsible for oversight of CTF Process Validation activities including, but not limited to Aseptic Process Simulations/ Validations (APS/APV), and other Lifecycle Management changes.Prepares written protocols/reports/summaries supporting validation studies.Ensures safe and compliant cGMP operations, maintains permanent inspection readiness.This position reports to the Associate Director of Manufacturing Science and Technology Validation. Qualification Bachelor's degree requiredKnowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline, is requiredExperience in Technical writing such as SOPs, protocols, summary reports and/or change controls.Manufacturing background with Manufacturing Science and Technology Validation experienceExperience in cGMP's and multi-national biopharmaceutical/cell therapy regulationsExcellent verbal/written communication skillsA minimum of 2 years' experience in biopharmaceutical operations, or its equivalent is required.Work Schedule: Mon-Fri (normal business hours)Editing and auditing batch records, documentation etc.Aseptic process validation and process validation required Benefits Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics. Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. 401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins. Synectics is an equal opportunity employer.