Job Title: Design Engineer

Location: MA

Duration: [Contract / Full-Time]

Experience: 4+

Job Summar

yWe are seeking a Design Engineer with a strong background in the pharmaceutical or biotechnology industry. The ideal candidate will be responsible for designing, developing, and optimizing equipment, systems, and processes used in GMP-regulated environments. This role requires collaboration with cross-functional teams to ensure designs meet regulatory, safety, and operational requirements

.Key Responsibilitie

sDesign and develop equipment, systems, and layouts for pharmaceutical/biotech manufacturing facilitie
sSupport process design including upstream/downstream equipment, clean utilities, and facility layou
tPrepare and review engineering drawings (P&IDs, layouts, isometrics
)Work closely with process, validation, and quality teams to ensure compliance with GMP standard
sParticipate in design reviews, risk assessments, and HAZOP studie
sSupport installation, commissioning, and qualification activities (IQ/OQ/PQ
)Ensure designs meet regulatory requirements (FDA, cGMP, GxP
)Coordinate with vendors for equipment specifications and technical evaluation
sAssist in troubleshooting and continuous improvement of systems and processe

sRequired Qualification

sBachelor’s degree in Mechanical, Chemical, or related Engineering fiel
d4+ years of experience in pharma or biotech industr
yStrong knowledge of GMP, FDA, and regulatory complianc
eExperience with process equipment such as bioreactors, filtration systems, CIP/SIP system
sProficiency in design tools such as AutoCAD, SolidWorks, or Revi
tExperience with P&IDs and engineering documentatio
nStrong communication and cross-functional collaboration skill

sPreferred Qualification

sExperience with cleanroom design and controlled environment
sKnowledge of upstream/downstream bioprocessin
gFamiliarity with validation and qualification processe
sExperience supporting capital projects or facility expansion

Shoolin Inc

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