Quality Engineer

2 weeks ago

Lake Forest, United States Actalent Full time

Quality Engineer We are seeking an advanced-level Quality Engineer with strong pharmaceutical experience to join our team in support of a drug?eluting temporary stent program. This role will focus on in?house manufacturing, drug coating processes, equipment validation, and regulatory submissions in accordance with ICH and other relevant standards. Responsibilities Lead quality engineering activities for the development and manufacturing of drug?eluting stents. Oversee drug coating processes, ensuring compliance with GMP, GLP, and ICH guidelines. Manage equipment validation protocols (IQ, OQ, PQ) and support qualification activities. Collaborate with R&D and manufacturing teams to optimize processes and ensure product quality. Assist in preparing regulatory submissions and documentation for FDA and international agencies. Support risk assessments, CAPAs, and root cause investigations related to product and process quality. Maintain and improve quality systems, documentation practices, and data integrity. Provide technical expertise in analytical methods and troubleshooting. Utilize laboratory software and data systems (e.g., LIMS, Chromeleon) to support quality operations. Essential Skills Bachelors degree (or higher) in engineering, chemistry, or a related field. Advanced?level experience in pharmaceutical or medical device quality engineering. Hands?on experience with equipment validation (IQ, OQ, PQ). Familiarity with drug coating processes and analytical chemistry techniques. Strong understanding of quality systems, GMP/GLP, and data integrity. 4+ years of experience in pharmaceutical manufacturing. Advanced experience in equipment validation. Knowledge of drug coating processes, engineering, validation, reliability engineering, failure analysis, report writing, regulatory submission, quality assurance, and quality engineering. Additional Skills & Qualifications Proficient in laboratory software and data systems. Excellent problem?solving, organizational, and communication skills. Hands?on experience with regulatory submissions (ICH, FDA). Job Type & Location Permanent position based out of Lake Forest, CA. Pay and Benefits The pay range for this position is $130,000.00 - $160,000.00 per year. Company Benefits Medical, dental, vision paid 100% by employer. Employee stock options. Workplace Type Fully onsite in Lake Forest, CA. Application Deadline Anticipated to close on Nov 30, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Equal Opportunity Statement Actalent is an equal?opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Reasonable Accommodation If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. #J-18808-Ljbffr

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