Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc… allowed, OfficeJob DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges.About the BusinessJoin our Pharma Services Group (PSG)—a global leader providing integrated drug development and manufacturing solutions to pharmaceutical and biotech companies. Our Greenville, North Carolina site specializes in sterile and oral solid dose (OSD) manufacturing, supported by advanced technologies and a highly collaborative team environment.Discover Impactful WorkAs an Engineer II, Computer Systems Validation (CSV), you will support validation activities tied to automation systems, manufacturing equipment, and computerized systems across the site. This role is primarily focused on change management and validation of existing commercial manufacturing systems, ensuring compliance and operational readiness.You will partner closely with automation, manufacturing, and quality teams to evaluate system changes, determine validation requirements, and execute qualification activities that maintain regulatory compliance and product quality.A Day in the LifeEvaluate changes to existing manufacturing systems, equipment, and related databasesSupport change management activities for commercial production linesAuthor and execute validation documentation including IQ/OQ/PQ protocols and qualification plansPerform risk assessments, validation assessments, and gap analyses to determine testing requirementsCollaborate with automation and engineering teams to qualify system changesSupport validation of automation and control systems (PLC, SCADA, DCS, DeltaV, etc.)Ensure compliance with cGMP, FDA, and industry standardsMaintain accurate and compliant validation documentationParticipate in continuous improvement and operational excellence initiativesWork Schedule & EnvironmentStandard schedule: Monday–Friday, 8:00 AM – 5:00 PMFlexibility required to support off-hours work during shutdowns or system availability windowsFully onsite role in Greenville, NCWork may occur in manufacturing or controlled environments as neededKeys to SuccessEducation (Required)Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical fieldEquivalencyEquivalent combinations of education, training, and relevant experience may be considered in place of a degreeExperience (Preferred, Not Required)Approximately 2 years of experience in validation, CSV, or a GMP-regulated environmentInternship, co-op, or academic project experience in validation, automation, or regulated industries will also be consideredKnowledge, Skills, AbilitiesFoundational understanding of cGMP and regulated environmentsExposure to Computer Systems Validation (CSV), CQV, or automation validationFamiliarity with automation/control systems (e.g., PLCs, SCADA, DCS, DeltaV, Allen-Bradley)Ability to support development of validation protocols (IQ/OQ/PQ)Strong technical writing and documentation skillsBasic understanding of risk assessments and gap analysisStrong analytical and problem‑solving skillsEffective communication and collaboration skillsAbility to manage multiple tasks in a fast‑paced environmentProficiency with Microsoft Office toolsPreferred QualificationsExperience working with automation engineers or manufacturing systemsExposure to change management processes in regulated environmentsFamiliarity with quality systems and validation lifecycle documentationCompetenciesDetail-orientedCollaborative team playerAdaptable and flexibleStrong communicatorQuality and compliance focusedAdditional InformationRole is primarily focused on Computer Systems Validation (CSV), with potential exposure to capital projects as business needs evolveThis position is not expected to independently lead full‑scale capital validation projects at this levelDesigned to support growth and development with guidance from experienced team members#J-18808-Ljbffr