MEP/CQV Engineer

MEP/CQV Engineer at Intellectt, Inc MEP/CQV Engineer at Intellectt, Inc in Winthrop, Massachusetts Posted in about 3 hours ago.

Type:

full-time

Job Description:

Project/Site Engineer - GxP Manufacturing (Boston, MA)

Location:

Boston / Cambridge, MA - on-site

Duration:

1+

Year Description:

We are looking for a qualified MEP project engineer with min 4 years of experience in pharma project engineering for the local client in Boston area for long-term contract.

Responsibility:

Provide day-to-day engineering support across facilities, utilities, and manufacturing systems in a GMP environment Author, execute, and own change controls within the client's quality management system and SOP framework Support commissioning, qualification, and validation activities including FAT, SAT, IQ, OQ, and PQ Review and develop engineering documentation: P&IDs, specifications, as-built drawings, and redline markups Participate in deviation investigations, CAPA development, and resolution Support inspection readiness activities and engage directly in regulatory audit preparation Provide technical oversight of A&E firms, equipment vendors, and subcontractors Troubleshoot equipment and system impairments; support planned shutdowns (typically August and December) Participate in operational meetings, continuous improvement initiatives, and engineering work order management Maintain GMP documentation to client and regulatory standards throughout

Qualification:

Bachelor's degree in Chemical, Mechanical, Electrical, or related Engineering discipline Minimum 4 years of engineering experience in oral solid dose, biotech, biopharma, or regulated pharmaceutical manufacturing in a GMP environment Hands-on experience with CQV lifecycle documentation: URS, FS, FAT/SAT, IQ/OQ/PQ, impact assessments, and traceability matrices Direct experience authoring and executing change controls in a regulated quality system Familiarity with cleanroom classifications: ISO 8/7/5 and Grade D/C/B/A environments Working knowledge of BMS, EMS, and SCADA systems Experience with a CMMS platform (Maximo, Blue Mountain, or equivalent) Ability to gown and work in aseptic manufacturing areas (client will administer gowning qualification) Strong GMP documentation discipline and attention to detail

Preferred:

Cell & gene therapy, aseptic fill-finish, or advanced therapy manufacturing experience Experience supporting FDA or EMA inspections Proficiency with electronic validation management systems (Kneat, ValGenesis, or equivalent) Familiarity with

ISPE GAMP, 21 CFR

Part 11, Annex 11, or CSA frameworks