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Project Engineer
Job
Intellectt, Inc
Malden, MA (In Person)
Full-Time
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Job Description
Project Engineer at Intellectt, Inc Project Engineer at Intellectt, Inc in Malden, Massachusetts Posted in about 23 hours ago.
Support the operation, maintenance, and troubleshooting of critical utility systems, includin g:
HVA C.Clean Stea m.
Water for Injection (WFI ).Compressed Gase s.
Process Pipin g.
Controlled Environment Utilitie s.
Author, execute, and manage change controls within the Quality Management System (QMS ).Support commissioning, qualification, and validation activities, including FAT, SAT, IQ, OQ, and P Q.Review, update, and develop engineering documentation, including P&IDs, equipment specifications, as-built drawings, and redline markup s.
Participate in deviation investigations and support CAPA development and implementatio n.
Assist with regulatory inspection readiness and support internal and external audit s.
Provide technical oversight for architectural and engineering firms, equipment vendors, and subcontractor s.
Troubleshoot equipment and facility issues and support planned maintenance shutdown activitie s.
Participate in engineering meetings, work order management, and continuous improvement initiative s.
Maintain accurate GMP documentation in accordance with regulatory and company requirement s.
Required Qualifications & Educatio n:
Bachelor's degree in Chemical, Mechanical, Electrical, or a related Engineering disciplin e.
Experien ceMinimum of 5 years of engineering experience in pharmaceutical, biotechnology, biopharmaceutical, or oral solid dose manufacturing within a GMP-regulated environmen t.
Demonstrated experience supporting GMP facility and utility systems, includin g:
HV ACW FIClean Ste amCIP/SIP Syste msEnvironmental Monitoring Syste msHands-on experience with Commissioning, Qualification, and Validation (CQV) lifecycle documentation, includin g:
U RSFunctional Specificatio nsFAT/S ATIQ/OQ/ PQImpact Assessmen tsTraceability Matric esDirect experience authoring and executing change controls in a regulated quality syste m.
Knowledge of cleanroom classifications, including
Working knowledge of Building Management Systems (BMS), Environmental Monitoring Systems (EMS), and SCADA platform s.
Experience with CMMS platforms such as Maximo, Blue Mountain, or equivalen t.
Ability to qualify for and work within aseptic manufacturing environment s.
Strong understanding of cGMP documentation practices and regulatory compliance requirement s.
Excellent troubleshooting, communication, and organizational skill s.
Preferred Qualificatio nsExperience in Cell & Gene Therapy, aseptic fill-finish, or advanced therapy manufacturing environment s.
Experience supporting FDA and/or EMA inspection s.
Familiarity with ISPE Baseline Guides related t o:
Commissioning & Qualificati onFacilities & Equipme ntWater & Steam Syste msExperience with electronic validation management systems such as Kneat, ValGenesis, or equivalen t.
Knowledge of
Previous experience working in a consulting or embedded engineering support mode l.
Preferred Technical Skill s.
GMP Facility Engineerin g.
Utilities Engineerin g.
CQV (Commissioning, Qualification & Validation ).Change Control Managemen t.
CAPA & Deviation Investigation s.
FAT/SAT Executio n.
Clean Utilitie s.
HVAC System s.
WFI & Clean Steam System s.
Type:
full-timeJob Description:
Job Title:
Project/Site Engineer -GxP Manufacturing Location:
Boston/Cambridge, MA (On-site, 5 days/week)Duration:
12+ Months (wiith extension of 2 years)Position Overview :
We are seeking an experienced Project/Site Engineer to provide engineering support for GMP manufacturing operations within a regulated pharmaceutical/biotechnology environment. The successful candidate will support facility and utility systems, commissioning and qualification activities, change management, and continuous improvement initiatives while ensuring compliance with FDA, cGMP, and industry standards .Key Responsibilitie s:
Provide day-to-day engineering support for facilities, utilities, and manufacturing systems in a GMP environmen t.Support the operation, maintenance, and troubleshooting of critical utility systems, includin g:
HVA C.Clean Stea m.
Water for Injection (WFI ).Compressed Gase s.
Process Pipin g.
Controlled Environment Utilitie s.
Author, execute, and manage change controls within the Quality Management System (QMS ).Support commissioning, qualification, and validation activities, including FAT, SAT, IQ, OQ, and P Q.Review, update, and develop engineering documentation, including P&IDs, equipment specifications, as-built drawings, and redline markup s.
Participate in deviation investigations and support CAPA development and implementatio n.
Assist with regulatory inspection readiness and support internal and external audit s.
Provide technical oversight for architectural and engineering firms, equipment vendors, and subcontractor s.
Troubleshoot equipment and facility issues and support planned maintenance shutdown activitie s.
Participate in engineering meetings, work order management, and continuous improvement initiative s.
Maintain accurate GMP documentation in accordance with regulatory and company requirement s.
Required Qualifications & Educatio n:
Bachelor's degree in Chemical, Mechanical, Electrical, or a related Engineering disciplin e.
Experien ceMinimum of 5 years of engineering experience in pharmaceutical, biotechnology, biopharmaceutical, or oral solid dose manufacturing within a GMP-regulated environmen t.
Demonstrated experience supporting GMP facility and utility systems, includin g:
HV ACW FIClean Ste amCIP/SIP Syste msEnvironmental Monitoring Syste msHands-on experience with Commissioning, Qualification, and Validation (CQV) lifecycle documentation, includin g:
U RSFunctional Specificatio nsFAT/S ATIQ/OQ/ PQImpact Assessmen tsTraceability Matric esDirect experience authoring and executing change controls in a regulated quality syste m.
Knowledge of cleanroom classifications, including
ISO 8, ISO 7, ISO
5, and Grade D/C/B/A environment s.Working knowledge of Building Management Systems (BMS), Environmental Monitoring Systems (EMS), and SCADA platform s.
Experience with CMMS platforms such as Maximo, Blue Mountain, or equivalen t.
Ability to qualify for and work within aseptic manufacturing environment s.
Strong understanding of cGMP documentation practices and regulatory compliance requirement s.
Excellent troubleshooting, communication, and organizational skill s.
Preferred Qualificatio nsExperience in Cell & Gene Therapy, aseptic fill-finish, or advanced therapy manufacturing environment s.
Experience supporting FDA and/or EMA inspection s.
Familiarity with ISPE Baseline Guides related t o:
Commissioning & Qualificati onFacilities & Equipme ntWater & Steam Syste msExperience with electronic validation management systems such as Kneat, ValGenesis, or equivalen t.
Knowledge of
ISPE GAMP, 21 CFR
Part 11, EU Annex 11, and Computer Software Assurance (CSA) methodologie s.Previous experience working in a consulting or embedded engineering support mode l.
Preferred Technical Skill s.
GMP Facility Engineerin g.
Utilities Engineerin g.
CQV (Commissioning, Qualification & Validation ).Change Control Managemen t.
CAPA & Deviation Investigation s.
FAT/SAT Executio n.
IQ/OQ/PQ
Protocol Development & Executio n.Clean Utilitie s.
HVAC System s.
WFI & Clean Steam System s.