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Company

CLA (CliftonLarsonAllen) · 20 hours ago

Qualification Engineer

Massachusetts, United States

Full-time

Remote

Mid Level

3+ years exp

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AccountingConsulting

Growth Opportunities

H1B Sponsor Likely

Hiring Manager

LeAnn Cantwell

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Responsibilities

Develop and execute commissioning protocols for new and existing equipment and systems, including Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).

Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and packaging equipment, utilities, and facilities.

Conduct process, cleaning, and computer systems validation to ensure consistent and reproducible results.

Prepare and maintain comprehensive documentation, including validation plans, protocols, reports, and traceability matrices. Managing the C&Q documentation and execution lifecycle from SLIA generation to OQ completion.

Ensure all activities comply with regulatory requirements, including FDA, EMA, and other relevant guidelines.

Participate in risk assessments and develop mitigation strategies to address potential validation issues.

Identify opportunities for process improvements and implement changes to enhance efficiency and compliance.

Work closely with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs. Provide cGMP leadership and guidance while delivering CQV services.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

CommissioningQualificationValidationGMPFDA regulationsLife sciencesTechnical writingValidation softwareASQ Certified Quality EngineerBiotech processesAseptic processingGene Therapy

Required

Bachelor’s degree in Engineering, Life Sciences, or a related field.

Minimum of 3 years of experience in commissioning, qualification, and validation within an FDA-regulated industry

Experience in facilities and equipment startup, walk-downs and troubleshooting, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation, execution, etc.

Strong understanding of GMP, FDA regulations, and industry standards.

Proficient in life science manufacturing processes in biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy, or equivalent experience.

Excellent problem-solving, analytical, and technical writing skills.

Proficiency in using validation software and tools.

Preferred

Relevant certifications (e.g., ASQ Certified Quality Engineer) are a plus.

Company

CLA (CliftonLarsonAllen)

Glassdoor

3.9

CLA exists to create opportunities for our clients, our people, and our communities through industry-focused wealth advisory, outsourcing, audit, tax, and consulting services.

Founded in 1960

Minneapolis, Minnesota, USA

5001-10000 employees

http://www.claconnect.com

H1B Sponsorship

CLA (CliftonLarsonAllen) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1)

2022 (3)

2021 (2)

2020 (1)