Process Engineer

Our client is seeking an experienced Process Engineer to support a biopharmaceutical manufacturing facility. This individual will provide engineering support across manufacturing equipment, facility utilities, laboratory systems, and related infrastructure, while also supporting equipment projects, troubleshooting, investigations, and qualification activities. This is a hands-on engineering role that will work closely with Manufacturing, Quality, Facilities, Validation, and other cross-functional teams. The ideal candidate has experience supporting equipment and utilities in a GMP/cGMP environment and is comfortable serving as a technical subject matter expert.Key ResponsibilitiesProvide engineering support for a portfolio of manufacturing equipment, facility utilities, laboratory equipment, and support systemsServe as a technical subject matter expert for assigned equipment and systemsTroubleshoot equipment and utility issues, identify root causes, and recommend corrective actionsSupport equipment-related deviation investigations, CAPAs, and change controlsProvide technical input into preventive maintenance strategies and equipment reliability initiativesIdentify and implement opportunities for equipment and process improvementsParticipate in engineering projects involving the design, procurement, installation, startup, commissioning, and qualification of new or modified equipment and systemsCollaborate with Manufacturing, Quality, Validation, Facilities, and other internal stakeholders on equipment-related initiativesWork with external vendors, contractors, and equipment suppliers as neededSupport equipment qualification and validation activitiesPrepare and review technical documentation, investigation reports, change controls, protocols, and other engineering documentationEnsure activities are performed in accordance with cGMP, SOPs, safety requirements, quality standards, and applicable regulatory expectationsSupport internal and external audits or regulatory inspections as a technical subject matter expertMaintain required training and documentation in a GMP-compliant state QualificationsBachelor's degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline5-7+ years of professional engineering, facilities, manufacturing, or operations experienceAt least 3 years of experience in a cGMP environment preferredExperience supporting GMP manufacturing equipment and/or facility utilitiesStrong troubleshooting and root-cause analysis skillsExperience with equipment qualification, validation, commissioning, or startup activitiesFamiliarity with change controls, deviations, CAPAs, and GMP documentationStrong technical writing and documentation skillsExcellent communication and interpersonal skillsAbility to work independently while effectively collaborating within a cross-functional teamStrong attention to detail, flexibility, and initiative Preferred ExperienceBiopharmaceutical, pharmaceutical, or biologics manufacturing experienceExperience with GMP utilities and manufacturing equipmentExperience supporting facility or manufacturing expansion projectsExperience with equipment commissioning and qualificationExperience working directly with equipment vendors, contractors, and engineering partnersExperience participating in regulatory inspections or GMP auditsMaster's degree in Engineering or a related technical discipline Location: Framingham, MA Schedule: 5 days onsite Type: Contract opportunity Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.