Associate Validation Engineer

United Pharma; Danvers (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma is seeking an Associate Validation Engineer to support medical device validation activities within a manufacturing and remediation environment. This role collaborates with Quality, Engineering, Manufacturing, and Operations teams to ensure compliant validation deliverables.

The ideal candidate has a strong engineering background (Electrical or Mechanical) and hands-on experience with IQ/OQ/PQ, TMV, and equipment qualification in a regulated medical device setting, plus solid

Qualifications

• Bachelor's degree in Engineering (Electrical or Mechanical preferred).
• 5-8 years of medical device validation experience.
• Hands-on experience with IQ/OQ/PQ and TMV.
• Experience with process validation and equipment qualification.
• Strong technical writing and documentation skills.

Responsibilities

• Execute IQ, OQ, and PQ protocols.
• Support process validation and equipment qualification activities.
• Develop and execute TMV protocol.
• Support inspection method validation activities.
• Assist with validation protocol generation, execution, and reporting.
• Support root cause investigations.
• Review and analyze validation data.
• Collaborate with Quality, Manufacturing, and Engineering teams.
• Support remediation and continuous improvement initiatives.
• Maintain validation documentation per FDA/ISO requirements.

Skills

IQ/OQ/PQ protocols

TMV validation

Root cause analysis

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering (Electrical or Mechanical preferred)

Tools

TMV protocol development

Job description

Seeking an Associate Validation Engineer to support medical device validation activities within a manufacturing and remediation environment. This role will support process validation, test method validation, inspection validation, and equipment qualification activities while working closely with Quality, Engineering, Manufacturing, and Operations teams.

The ideal candidate will possess a strong engineering foundation (Electrical or Mechanical) along with hands-on experience supporting validation activities within a regulated medical device environment.

Responsibilitie

• sExecute IQ, OQ, and PQ protocol
• sSupport process validation and equipment qualification activitie
• sDevelop and execute test method validation (TMV) protocol
• sSupport inspection method validation activitie
• sAssist with validation protocol generation, execution, and reportin
• gSupport root cause investigations associated with validation activitie
• sReview and analyze validation dat
• aCollaborate with Quality, Manufacturing, and Engineering team
• sSupport remediation and continuous improvement initiative
• sMaintain validation documentation in accordance with FDA and ISO requirement

Required Qualificatio

• nsBachelor's degree in Engineering (Electrical or Mechanical preferre
• d)5-8 years of medical device validation experien
• ceExperience wit
• h:IQ/OQ/
• PQProcess Validati
• onTest Method Validation (TM
• V)Inspection Method Validati
• onWorking knowledge of FDA Quality System requiremen
• tsStrong technical writing and documentation skil

Preferred Qualificati

onsElectrical Open

• ingElectrical Engineering backgro
• undElectronics manufacturing experie
• nceSoldering experie

ionMechanical Open

• ingMechanical Engineering backgro
• undManufacturing process validation experie