Quality Assurance Engineer

Job Description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it's about more than just a job-it's about your career and your future.

Your Role

We are hiring an experienced senior-level Quality Assurance Engineer to support the commissioning, qualification, and validation program and operational readiness for a new pharmaceutical facility. In this role, you will be responsible for ensuring the quality and reliability of our facilities, utilities, and process equipment through testing, validation, and quality assurance processes. The ideal candidate will have a strong background in quality engineering and experience with facility start-ups, with an advanced understanding of industry best practices.

• Complete quality reviews for CQV documentation for new pharmaceutical facility.
• Support the CQV program and operational readiness on new utilities and process equipment.
• Provide 'on the floor' quality engineering during validation executions.
• Conduct risk assessments and manage quality risks using tools like FMEA to ensure safety, reliability, and compliance with relevant industry standards and regulations.
• Perform thorough analysis and interpretation of test results, identifying deviations, anomalies, and areas for improvement, and provide recommendations for corrective actions.
• Define validation requirements, including test objectives, scope, methodologies, and acceptance criteria, based on project specifications and customer requirements.
• Collaborate with cross-functional teams to ensure effective communication and alignment of validation efforts.
• Stay up-to-date with emerging trends, technologies, and best practices in validation engineering and quality assurance, and proactively apply this knowledge to enhance validation processes and methodologies.
• Other duties as assigned.

Requirements

Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

Equal Opportunity Employment Statement :

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to : recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived : race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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