Entry Level Quality Validation Engineer- HPLC/ISO 13485/ISO 14971

Entry Level Quality Validation Engineer- HPLC/ISO 13485/ISO 14971 at Collabera Entry Level Quality Validation Engineer- HPLC/ISO 13485/ISO 14971 at Collabera in Niles, Illinois Posted in about 22 hours ago.

Type:

full-time

Job Description:

Job Summary:

We are seeking an experienced Senior Validation Engineer to support critical manufacturing expansion initiatives within a highly regulated production environment. This role will focus on qualification and validation activities related to new manufacturing equipment, facility utility expansion, automation systems, process validation, and analytical test method validation. The position will work closely with quality, engineering, manufacturing, and compliance teams to ensure all validation deliverables meet regulatory and business standards while supporting high product quality outcomes.

Key Responsibilities:

• Partner with cross-functional engineering, quality, manufacturing, and technical teams to support validation project execution.
• Review, author, and approve qualification and validation protocols, reports, and supporting documentation.
• Lead installation qualification, operational qualification, and performance qualification activities for new manufacturing equipment and facility utility expansion.
• Support automation validation and manufacturing system qualification in alignment with internal procedures and regulatory requirements.
• Execute process validation activities associated with production scale-up and manufacturing changes.
• Support analytical and test method validation activities, particularly related to synthesis, purification, and laboratory testing processes.
• Participate in qualification efforts involving high-performance liquid chromatography systems and associated manufacturing applications.
• Ensure all validation packages comply with current Good Manufacturing Practices and applicable quality standards.
• Support change control projects related to on-market products, manufacturing enhancements, and process improvements.
• Collaborate with stakeholders to resolve deviations, documentation gaps, and validation issues in a timely manner.
• Drive technical writing accuracy, completeness, and audit readiness across all qualification records.
• Contribute to continuous compliance initiatives and successful project milestone completion.

Required Qualifications:

• Bachelor's degree in Life Science, Engineering, or a closely related technical discipline
• Minimum 5 years of professional experience in validation, quality engineering, or regulated manufacturing environments
• Hands-on experience supporting equipment qualification and process validation projects
• Strong knowledge of manufacturing expansion, facility utility qualification, and automation validation
• Experience with analytical method validation and laboratory process qualification
• Working knowledge of FDA regulations, Good Manufacturing Practices, and quality compliance standards
• Strong technical documentation, protocol writing, and report review experience
• Excellent verbal and written communication skills
• Proven ability to work collaboratively across multiple technical functions

Preferred Qualifications:

• Bachelor's or Master's degree in Chemical, Electrical, Biomedical, Mechanical, or related Engineering discipline
• Prior experience within pharmaceutical, biotechnology, medical device, or other highly regulated industries
• Knowledge of ISO 13485 and

ISO 14971

standards

• Experience supporting high-performance liquid chromatography validation activities
• Demonstrated success driving compliant validation deliverables within aggressive project timelines

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually, as applicable.

Pay Range:

$30/hr to $36/hr