Validation Engineer III at Thermo Fisher Scientific

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAble to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cold Room/Freezers -22degreesF/-6degrees C Laboratory Setting Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job DescriptionDivision Specific InformationCTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time a concept that we internally accept as There is a Patient Waiting. Our unique blend of services includes project management packaging distribution transportation management and specialty logistics ancillary supply management clinical supply optimization bio-repository storage and much more. Our more than 3500 employees in over 15 countries work hard every day knowing that what they do matters.Location4650 New Design RdFrederick MDHow will you make an impactAs part of our distributed team what you do contributes directly to our mission; enabling our customers to make the world healthier cleaner and safer.What will you doAs a Validation Engineer III you will be responsible to interact with several departments to provide validation support for computer systems equipment and processes along with the critical utilities and facilities required for packaging operations at the site. You will ensure site compliance and all vital activities are performed on time to keep all validated systems in a validated state. This role requires full-time onsite presence at our Frederick MD location.Responsibilities:Responsible for the preparation and execution of validation documentation (VP IQ OQ PQ) as well as the generation of corresponding summary reportsPosition will support the generation of Process Performance Qualification (PPQ) documentation including Control Strategy Product Knowledge assessment Process Failure Modes and Effects Analysis Validation Strategy and PPQ.Generate complete and review protocols for controlled temperature units (Freezers and Coldrooms) and packaging equipmentPerform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment processes materials and facilities.Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices)Analyze the results of testing and resolve acceptability of results against pre-determined criteria.Identify protocol discrepancies from established product or process standards and provide recommendations for resolving themPrepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocolsCoordinate with other departments or outside contractors/vendors to complete validation tasksDemonstrates and promotes the company vision of the 4 Is: Integrity Intensity Innovation and involvementAuthor SOPs (Standard Operating Procedures) and Validation Documentation within DocumentumConducts all activities in a safe and efficient mannerOther duties may be assigned to meet business needsEducation:A four-year Bachelor of Science degree from an accredited college or university in an Engineering or Science field and 2-5 years of validation experience in a regulated industry or equivalent validation experience including five years of food or pharmaceutical packaging or cGMP experienceMinimum Qualifications:Knowledge of Computer System Validation (CSV)Knowledge of Controlled Temperature Unit Operation and ManagementPC literacy including the ability to generate sophisticated documents in both Microsoft Excel and Microsoft WordMust have strong analytical skillsNeeds to be capable of multitasking and responding to shifting prioritiesMust have good communication skills both written and verbalMust be results orientedMust have prior mechanical and process equipment experienceDesired Qualifications:Knowledge of pharmaceutical packaging materials and equipmentPhysical RequirementsMust be able to lift 35 poundsAt Thermo Fisher Scientific each one of our >100000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer!Compensation and BenefitsThe salary range estimated for this position based in Maryland is $83300.00$128000.00.This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:A choice of national medical and dental plans and a national vision plan including health incentive programsEmployee assistance and family support programs including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policyRetirement and savings programs such as our competitive 401(k) U.S. retirement savings planEmployees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountFor more information on our benefits please visit: Key Skills Python,SOC,Debugging,C/C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 83300 - 128000