{"schemaVersion":"jobsearcher.job.v1","id":"b232e422ef3c7a455c30ea9c","url":"https://jobsearcher.com/jobs/b232e422ef3c7a455c30ea9c","canonicalUrl":"https://jobsearcher.com/jobs/b232e422ef3c7a455c30ea9c","title":"Senior Process Engineer","description":"SUMMARY\nIndependently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.\nPREFERRED QUALIFICATIONS\nMust have experience with the Packaging and Manufacturing Process\nDevelop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.\nDefine system boundaries and identify direct/indirect impact systems.\nLead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.\nOversee and/or execute commissioning activities including FAT, SAT, and field commissioning.\nAuthor, review, and approve qualification protocols (IQ, OQ, PQ) and lead and document risk assessments related to system qualification.\nEvaluate and manage change controls impacting validated systems.\nAssess impact of deviations and implement corrective and preventive actions (CAPA).\nCollaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.\nDevelop the characterization protocols and execute the characterization activities.\nDevelop and review the characterization reports.\nKnowledge in SAP, TrackWise, electronic batch records (PAS/X) , and documents management systems (Veeva).\nMaintenance knowledge and experience with automated and manual inspection equipment operation.\nApply sophisticated and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or projects.\nApply standard engineering techniques and procedures to improve equipment reliability and performance\nBasic knowledge with GMP, validation and documentation processes in a highly regulated environment. Protocol Development and execution requirements.\nEDUCATION\n-Doctorate OR\n-Masters + 2 years of Engineering experience OR\n-Bachelors in Engineering + 4 years of Engineering experience.\nSHIFT\nMonday to Friday. 8 hours per day, 40 hours per week. Work schedule flexibility as required.\nFUNCTIONS\nGeneral:\n1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.\n2. Develop engineering policies and procedures that affect multiple organizational units.\n3. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.\n4. Employ advanced engineering techniques and/or modifications of advanced techniques within the area of engineering expertise.\n5. Apply knowledge of engineering principles and practices outside of the area of discipline expertise to a broad variety of assignments in related fields.\n6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.\n7. Application of mature engineering knowledge in planning and conducting projects.\n*Other functions may be assigned\nDesign Engineering:\n1. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.\n2. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.\n3. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.\n4. Coordinate the work of consultants, architects and engineering firms on development of standard design documents.\n5. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project\nCOMPETENCIES/SKILLS\n1. Working knowledge of pharmaceutical/biotech processes\n2. Familiarity with validation processes\n3. Familiarity with documentation in a highly regulated environment\n4. Ability to operate specialized laboratory equipment and computers as appropriate.\n5. Ability to interpret and apply GLPs and GMPs.\n6. Ability to apply engineering science to production.\n7. Able to develop solutions to routine technical problems of limited scope\nDemonstrated skills in the following areas:\n-Problem solving and applied engineering.\n-Basic technical report writing\n-Verbal communication\n-Comprehensive understanding of validation protocol execution requirements.\nDemonstrated Skills in the following areas:\n-Basic technical presentations o Personal Organization o Validation Protocol Writing\n-Dealing with and managing change o Technical (Equipment Specific)\n-Analytical Problem Solving o Computer Literacy\n-Specialized equipment/process expertise\n-In-depth knowledge of validation processes and requirements as applied to new equipment installations\n-Interacts effectively with variety of communication and working styles\n-Ability to independently determine when additional internal resources are required to solve problems\n-Ability to handle multiple projects at one time\nDemonstrated Skills in the following areas:\n-Schedule development o Facilitation\n-Collaboration\n-Basic project management o Completion and follow-up\n-Established expertise in at least 3 separate areas of engineering technology.\n-Ability to independently determine when additional external resources are required to solve problems\n-Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope\n-Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach\n-Working knowledge of financial analysis tools\n-Ability to delegate and manage the project work of others\nDemonstrated Skills in the following areas:\n-Negotiation, persuasion and facilitation\n-Collaboration\n-Project cost development\n-Conflict Resolution\n-Leadership and teambuilding\n-Management of contractors and vendors\nPay: $48.00 - $51.00 per hour\nExperience:\nGMP: 3 years (Preferred)\nSAP: 3 years (Preferred)\nSAP Manufacturing: 3 years (Preferred)\nWork Location: In person","company":"Innovaworkforce","rawCompany":"innovaworkforce","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-08-03T17:12:21.245Z","occupations":[{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Process Engineer","description":"SUMMARY\nIndependently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.\nPREFERRED QUALIFICATIONS\nMust have experience with the Packaging and Manufacturing Process\nDevelop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.\nDefine system boundaries and identify direct/indirect impact systems.\nLead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.\nOversee and/or execute commissioning activities including FAT, SAT, and field commissioning.\nAuthor, review, and approve qualification protocols (IQ, OQ, PQ) and lead and document risk assessments related to system qualification.\nEvaluate and manage change controls impacting validated systems.\nAssess impact of deviations and implement corrective and preventive actions (CAPA).\nCollaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.\nDevelop the characterization protocols and execute the characterization activities.\nDevelop and review the characterization reports.\nKnowledge in SAP, TrackWise, electronic batch records (PAS/X) , and documents management systems (Veeva).\nMaintenance knowledge and experience with automated and manual inspection equipment operation.\nApply sophisticated and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or projects.\nApply standard engineering techniques and procedures to improve equipment reliability and performance\nBasic knowledge with GMP, validation and documentation processes in a highly regulated environment. Protocol Development and execution requirements.\nEDUCATION\n-Doctorate OR\n-Masters + 2 years of Engineering experience OR\n-Bachelors in Engineering + 4 years of Engineering experience.\nSHIFT\nMonday to Friday. 8 hours per day, 40 hours per week. Work schedule flexibility as required.\nFUNCTIONS\nGeneral:\n1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.\n2. Develop engineering policies and procedures that affect multiple organizational units.\n3. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.\n4. Employ advanced engineering techniques and/or modifications of advanced techniques within the area of engineering expertise.\n5. Apply knowledge of engineering principles and practices outside of the area of discipline expertise to a broad variety of assignments in related fields.\n6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.\n7. Application of mature engineering knowledge in planning and conducting projects.\n*Other functions may be assigned\nDesign Engineering:\n1. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.\n2. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.\n3. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.\n4. Coordinate the work of consultants, architects and engineering firms on development of standard design documents.\n5. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project\nCOMPETENCIES/SKILLS\n1. Working knowledge of pharmaceutical/biotech processes\n2. Familiarity with validation processes\n3. Familiarity with documentation in a highly regulated environment\n4. Ability to operate specialized laboratory equipment and computers as appropriate.\n5. Ability to interpret and apply GLPs and GMPs.\n6. Ability to apply engineering science to production.\n7. Able to develop solutions to routine technical problems of limited scope\nDemonstrated skills in the following areas:\n-Problem solving and applied engineering.\n-Basic technical report writing\n-Verbal communication\n-Comprehensive understanding of validation protocol execution requirements.\nDemonstrated Skills in the following areas:\n-Basic technical presentations o Personal Organization o Validation Protocol Writing\n-Dealing with and managing change o Technical (Equipment Specific)\n-Analytical Problem Solving o Computer Literacy\n-Specialized equipment/process expertise\n-In-depth knowledge of validation processes and requirements as applied to new equipment installations\n-Interacts effectively with variety of communication and working styles\n-Ability to independently determine when additional internal resources are required to solve problems\n-Ability to handle multiple projects at one time\nDemonstrated Skills in the following areas:\n-Schedule development o Facilitation\n-Collaboration\n-Basic project management o Completion and follow-up\n-Established expertise in at least 3 separate areas of engineering technology.\n-Ability to independently determine when additional external resources are required to solve problems\n-Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope\n-Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach\n-Working knowledge of financial analysis tools\n-Ability to delegate and manage the project work of others\nDemonstrated Skills in the following areas:\n-Negotiation, persuasion and facilitation\n-Collaboration\n-Project cost development\n-Conflict Resolution\n-Leadership and teambuilding\n-Management of contractors and vendors\nPay: $48.00 - $51.00 per hour\nExperience:\nGMP: 3 years (Preferred)\nSAP: 3 years (Preferred)\nSAP Manufacturing: 3 years (Preferred)\nWork Location: In person","datePosted":"2026-08-03T17:12:21.245Z","dateModified":"2026-08-03T17:12:21.245Z","hiringOrganization":{"@type":"Organization","name":"Innovaworkforce","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b232e422ef3c7a455c30ea9c"},"url":"https://jobsearcher.com/jobs/b232e422ef3c7a455c30ea9c"}}