Aerospace, manufacturing, engineering, biotech and pharmaceutical, and more.
Apollo Professional Solutionshttps://www.apollopros.com/wp-content/uploads/2022/05/ApolloLogo600.pnghttps://www.apollopros.comhttps://www.apollopros.comUSD99114HOURtrue
Contract Quality Engineer – Onsite | Hillsboro, OR
About the Opportunity:
Join a high-impact manufacturing site that plays a critical role in delivering millions of units of life-saving medicines to patients worldwide. This site supports both commercial products and pipeline innovation through robust drug product and finished goods manufacturing. As a Contract Quality Engineer, you will be an integral part of the Qualification and Validation (Q&V) program, ensuring quality and compliance in equipment, utilities, processes, and computerized systems.
What You’ll Do:
As a Quality Engineer, you’ll bring your expertise in validation principles and quality systems to provide oversight for a variety of site operations. Your focus will be on ensuring all qualification and validation activities are compliant, consistent, and aligned with regulatory expectations.
Key responsibilities include:
Overseeing validation activities related to equipment, facilities, utilities, GMP computerized systems, manufacturing processes, cleaning procedures, sterilization, and analytical methods.
Supporting technology transfer and process validation activities with a quality-driven mindset.
Reviewing and approving qualification and validation documentation to ensure it meets internal and regulatory standards.
Providing guidance on best practices to internal teams, helping ensure reproducibility and compliance.
Evaluating and approving changes that could impact the validated state, offering strategic input on quality implications.
Investigating and assessing exceptions and deviations related to Q&V activities, ensuring thorough documentation and resolution.
Applying critical thinking to complex issues, often requiring cross-functional collaboration and analysis of various inputs.
What You’ll Bring:
A Bachelor’s degree with 8+ years of industry experience, or a Master’s degree with 5+ years of relevant experience.
Proven experience in the biopharmaceutical or pharmaceutical industry, particularly in technical or quality validation.
Strong working knowledge of qualification and validation standards and the ability to apply them to real-world scenarios.
Deep understanding of cGMP regulations and other applicable quality standards.
Skilled in interpreting quality requirements and translating them into effective execution and oversight.
Ability to work both independently and collaboratively, using sound judgment to make quality and technical decisions.
Flexibility and commitment to meet shifting priorities and deadlines in a dynamic manufacturing environment.
Excellent communication and interpersonal skills, with the ability to engage cross-functional partners and drive alignment.
This role offers the opportunity to work onsite at a cutting-edge facility, contributing directly to the quality and success of a global portfolio of therapeutic products. If you're ready to bring your validation expertise to a mission-driven team, we want to hear from you.
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
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