Process Engineer

Validation &

• Engineering Group Inc V&EG a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas Laboratory Compliance Computer Engineering Project Management Validation and other services We are seeking an experienced Process Engineer to provide technical engineering support within a regulated pharmaceuticalbiotechnology manufacturing environment The Process Engineer will work closely with Engineering Manufacturing Quality Validation Maintenance and other cross functional teams to support process performance equipment and system improvements troubleshooting capital projects and continuous improvement initiatives The ideal candidate is a hands on engineer with strong technical problem solving skills experience working in GMP regulated manufacturing environments and the ability to independently manage engineering activities from problem identification through implementation and closure Description Provide day to day process engineering support to manufacturing and engineering operationsEvaluate process performance and identify opportunities to improve reliability efficiency capacity quality and operational performanceLead or support troubleshooting and root cause investigations related to manufacturing processes equipment and systemsDevelop and implement engineering solutions to address process and equipment issuesSupport capital projects equipment upgrades system modifications and process improvement initiativesDevelop and review technical documentation including engineering assessments specifications protocols reports procedures and change control documentationSupport equipment and process design reviews technical evaluations and implementation activitiesCoordinate engineering activities with Manufacturing Quality Validation Automation Maintenance and other technical groupsSupport commissioning qualification validation startup and turnover activities as requiredParticipate in change controls deviations investigations CAPAs and risk assessments from an engineering perspectiveAnalyze process and equipment data to identify trends recurring issues and improvement opportunitiesProvide technical recommendations and support the development of corrective and preventive solutionsCoordinate activities with vendors contractors and equipment suppliers when requiredEnsure engineering activities are performed in accordance with applicable GMP requirements engineering standards procedures and safety expectationsMaintain clear documentation and communicate project status technical issues risks and recommendations to stakeholdersSupport continuous improvement and standardization initiatives within the Engineering organizationQualifications Bachelors degree in Chemical Engineering Mechanical Engineering Industrial Engineering Bioengineering or a related engineering disciplineRelevant process engineering experience within the pharmaceutical biotechnology medical device or regulated manufacturing industryStrong understanding of manufacturing processes equipment utilities and engineering principlesExperience troubleshooting process and equipment related issues in a manufacturing environmentKnowledge of GMP requirements change control deviations CAPA and engineering documentation practicesExperience supporting equipment modifications process improvements or capital projectsAbility to analyze technical data and translate findings into practical engineering solutionsStrong technical writing documentation and communication skillsDemonstrated ability to work independently while collaborating effectively with multidisciplinary teamsStrong organizational skills with the ability to manage multiple activities and priorities5 years of relevant process or manufacturing engineering experience within the pharmaceutical or biotechnology industryExperience supporting biopharmaceutical manufacturing processes and equipmentExperience with commissioning qualification validation and equipment startupFamiliarity with process optimization process characterization troubleshooting methodologies and root cause analysisExperience supporting capital projects and equipmentsystem lifecycle activitiesWorking knowledge of automation and process control systemsExperience working in a highly regulated GMP manufacturing environmentKey Competencies Process Engineering Manufacturing Support Troubleshooting Root Cause Analysis Process Optimization Equipment &
• Systems Technical Documentation Change Control CAPA GMP Compliance Capital Projects CQV Support Cross Functional Collaboration Continuous Improvement At Validation &
• Engineering Group people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together We look forward to hearing from you Validation &
• Engineering Group is an equal opportunity employer All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status