Quality Engineer

Petersburg, VA - USA

Monthly Salary: Not Disclosed

Experience Required: 5-7years

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 Engineer to support the commissioning qualification and validation program and operational readiness for a new pharmaceutical 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

Bachelors Degree in engineering or life sciences related from a four-year university.
5-10 years of experience in quality engineering with experience working at sites manufacturing sterile injectable pharmaceuticals.
Experience with facility startups and supporting CQV of utilities and equipment.
Advanced knowledge of GMP environments.
Excellent interpersonal and communication skills verbal and written.
Ability to provide proactive follow-ups and drive project completion.
Ability to work well on a team.
Excellent problem-solving and analytical skills with the ability to identify investigate and resolve complex validation issues.
Detail-oriented mindset with a focus on accuracy precision and compliance.
Strong organizational and time management skills with the ability to manage multiple projects and priorities simultaneously.
Must be able to work on-site.

Benefits

W2 Temp positions include our medical and sick time benefits.

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.

#LI-RW1

The Experience

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

Your Role

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

Bachelors Degree in engineering or life sciences related from a four-year university.
5-10 years of experience in quality engineering with experience working at sites manufacturing sterile injectable pharmaceuticals.
Experience with facility startups and supporting CQV of utilities and equipment.
Advanced knowledge of GMP environments.
Excellent interpersonal and communication skills verbal and written.
Ability to provide proactive follow-ups and drive project completion.
Ability to work well on a team.
Excellent problem-solving and analytical skills with the ability to identify investigate and resolve complex validation issues.
Detail-oriented mindset with a focus on accuracy precision and compliance.
Strong organizational and time management skills with the ability to manage multiple projects and priorities simultaneously.
Must be able to work on-site.