Title: Validation Engineer (Injection Molding / Injectables / Automation)
Location: Buffalo Grove, Illinois
Hire Type: Contract
Shift: 1st Shift / Standard Business Hours
Benefits:
As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.
Must Have Skill Set:
5+ years of validation engineering experience in regulated manufacturing environments
Hands-on experience with injection molding processes and equipment validation
Experience supporting injectable pharmaceutical, biologics, or sterile manufacturing operations
Strong knowledge of IQ/OQ/PQ, CSV, and lifecycle validation principles
Experience validating automated manufacturing equipment, PLC-controlled systems, or integrated automation platforms
Working knowledge of GMP, FDA, 21 CFR Part 11, and validation documentation requirements
Experience with process equipment qualification, protocol execution, deviation investigations, and change control
Strong technical writing and cross-functional communication skills
Overview:
We are seeking a Validation Engineer with experience in injection molding, injectable manufacturing, and automation systems to support validation activities within a regulated manufacturing environment. This role will be responsible for qualification and validation of manufacturing equipment, automated production systems, process improvements, and facility-related projects.
The ideal candidate will have hands-on experience validating injection molding equipment used in medical device or pharmaceutical production, along with familiarity supporting sterile/injectable manufacturing processes and automation-driven production environments. This individual will partner closely with engineering, manufacturing, quality, automation, and project teams to ensure compliant implementation and operational readiness of equipment and processes.
Job Duties:
Develop, execute, and approve validation protocols including IQ, OQ, PQ, TMV, and process validation documentation
Support qualification and validation of injection molding equipment, automation systems, and manufacturing process equipment
Validate production equipment used in injectable pharmaceutical or sterile manufacturing environments
Collaborate with automation engineers to qualify PLC-controlled systems, HMI interfaces, SCADA systems, and integrated manufacturing equipment
Support commissioning and startup activities for new manufacturing equipment and capital projects
Execute risk assessments, FAT/SAT activities, and validation impact assessments
Investigate validation deviations, implement CAPAs, and support change control activities
Ensure validation deliverables align with internal SOPs, GMP standards, FDA regulations, and industry best practices
Partner cross-functionally with Quality, Manufacturing, Engineering, Automation, and Project Management teams
Review P&IDs, equipment specifications, URS documents, and functional design specifications
Support process improvements and revalidation efforts tied to manufacturing changes or equipment upgrades
Maintain accurate validation documentation and support audit readiness activities
Qualifications:
Required Qualifications:
Bachelor's degree in Engineering, Life Sciences, or related technical discipline
5+ years of validation engineering experience in pharmaceutical, medical device, biotech, or regulated manufacturing environments
Direct experience with injection molding equipment validation
Experience supporting injectable, sterile, or aseptic manufacturing operations
Strong knowledge of validation lifecycle methodology and GMP compliance
Experience with automated manufacturing equipment and control systems
Strong protocol writing, execution, and technical documentation experience
Ability to troubleshoot technical issues and work effectively in cross-functional teams
Preferred Qualifications:
Experience in medical device manufacturing involving molded plastic components
Familiarity with DeltaV, Allen-Bradley PLCs, Siemens, SCADA, or MES systems
Experience supporting equipment used in cleanroom or aseptic manufacturing environments
Exposure to packaging validation, serialization, or automated inspection systems
Previous experience supporting FDA inspections or internal audits
Email- avinashk@stellentit.com Phone Number : +1 321 7856 062
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