Validation Engineer

Job Description

Job Description

Title: Validation Engineer (Injection Molding / Injectables / Automation)

Location:Buffalo Grove

Hire Type: Contract

Shift: 1st Shift / Standard Business Hours

Compensation:$55-70/hr.

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