Validation Engineer

Validation Engineer (Injection Molding / Injectables / Automation)

Location:

Buffalo Grove

Hire Type:
Contract

Shift: 1st Shift / Standard Business Hours

Compensation: $55-70/hr.

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. (Modify if direct hire.)

• 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 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

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.

• 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

• 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

• 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

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity,