Validation Engineer

Job Description Title: Validation Engineer (Injection Molding / Injectables / Automation)Want to apply Read all the information about this position below, then hit the apply button.Location:Buffalo GroveHire Type: ContractShift: 1st Shift / Standard Business HoursCompensation:$55-70/hr.Benefits:As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.(Modify if direct hire.)Must Have Skill Set:5+ years of validation engineering experience in regulated manufacturing environmentsHands-on experience with injection molding processes and equipment validationExperience supporting injectable pharmaceutical, biologics, or sterile manufacturing operationsStrong knowledge of IQ/OQ/PQ, and lifecycle validation principlesExperience validating automated manufacturing equipment, PLC-controlled systems, or integrated automation platformsWorking knowledge of GMP, FDA, 21 CFR Part 11, and validation documentation requirementsExperience with process equipment qualification, protocol execution, deviation investigations, and change controlStrong technical writing and cross-functional communication skillsOverview:We are seeking a Validation Engineer with experience in injection molding, injectable manufacturing, and automation systems to support validation activities within a regulated manufacturing environment. This role will be responsible for qualification and validation of manufacturing equipment, automated production systems, process improvements, and facility-related projects.The ideal candidate will have hands-on experience validating injection molding equipment used in medical device or pharmaceutical production, along with familiarity supporting sterile/injectable manufacturing processes and automation-driven production environments. This individual will partner closely with engineering, manufacturing, quality, automation, and project teams to ensure compliant implementation and operational readiness of equipment and processes.Job Duties:Develop, execute, and approve validation protocols including IQ, OQ, PQ, TMV, and process validation documentationSupport qualification and validation of injection molding equipment, automation systems, and manufacturing process equipmentValidate production equipment used in injectable pharmaceutical or sterile manufacturing environmentsCollaborate with automation engineers to qualify PLC-controlled systems, HMI interfaces, SCADA systems, and integrated manufacturing equipmentSupport commissioning and startup activities for new manufacturing equipment and capital projectsExecute risk assessments, FAT/SAT activities, and validation impact assessmentsInvestigate validation deviations, implement CAPAs, and support change control activitiesEnsure validation deliverables align with internal SOPs, GMP standards, FDA regulations, and industry best practicesPartner cross-functionally with Quality, Manufacturing, Engineering, Automation, and Project Management teamsReview P&IDs, equipment specifications, URS documents, and functional design specificationsSupport process improvements and revalidation efforts tied to manufacturing changes or equipment upgradesMaintain accurate validation documentation and support audit readiness activitiesQualifications:Required Qualifications:Bachelor’s degree in Engineering, Life Sciences, or related technical discipline xaygatp 5+ years of validation engineering experience in pharmaceutical, medical device, biotech, or regulated manufacturing environmentsDirect experience with injection molding equipment validationExperience supporting injectable, sterile, or aseptic manufacturing operationsStrong knowledge of validation lifecycle methodology and GMP complianceExperience with automated manufacturing equipment and control systemsStrong protocol writing, execution, and technical documentation experienceAbility to troubleshoot technical issues and work effectively in cross-functional teamsPreferred Qualifications:Experience in medical device manufacturing involving molded plastic componentsFamiliarity with DeltaV, Allen-Bradley PLCs, Siemens, SCADA, or MES systemsExperience supporting equipment used in cleanroom or aseptic manufacturing environmentsExposure to packaging validation, serialization, or automated inspection systemsPrevious experience supporting FDA inspections or internal auditsQualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity,