Quality Engineer
Quality Engineer
Posted on :
14-11-2024
Employer Active
1 Vacancy
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Jobs by Experience
3-5years
Monthly Salary
80 - 90
Vacancy
1 Vacancy
Posted on :
14-11-2024
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 multicultural 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 Quality Engineer responsible for ensuring the highest quality standards in our production and validation processes implementing process improvements and conducting thorough investigations risk management and corrective action implementation to ensure regulatory compliance.
- Provide technical quality process and validation expertise and onthefloor support.
- Monitor and analyze production processes and validation testing to ensure compliance with regulatory requirements.
- Analyze data from validation tests to determine systems and processes meet required criteria and specifications.
- Conduct investigations and root cause analysis to best implement corrective actions for process deviations and quality issues.
- Provide through quality review and approval of required validation lifecycle documentation including commissioning qualification validation protocols reports records etc.
- Evaluates nonconformances performs gap analyses and takes appropriate action to efficiently resolve deficiencies.
- Collaborate with crossfunctional teams to identify and implement process improvements.
- Additional responsibilities as required.
Requirements
- Bachelor s degree in Engineering Life Sciences or a related field.
- 35 years of proven experience in quality process and or validation engineering in the pharmaceutical and/or biotech industry.
- Experience with manufacturing process equipment.
- Strong knowledge of GMP FDA regulations and other relevant industry standards.
- Proven success in risk management; experienced conducting nonconformance and deviation investigations and executing CAPA implementation.
- Experience with validation lifecycle management and riskbased approaches.
- Excellent analytical and technical problem solving skills.
- Strong technical writing skills and understanding of full lifecycle documentation (protocols reports procedures risk assessments specifications and requirements etc.)
- Effective communication and interpersonal skills.
- Proactive with strong organization time management and project management abilities.
- Excellent attention to detail with commitment to quality and compliance.
- At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
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 employersponsored 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.
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 employersponsored 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.
#LIRW1
Bachelor s degree in Engineering, Life Sciences, or a related field. 3-5 years of proven experience in quality, process, and or validation engineering in the pharmaceutical and/or biotech industry. Experience with manufacturing process equipment. Strong knowledge of GMP, FDA regulations, and other relevant industry standards. Proven success in risk management; experienced conducting non-conformance and deviation investigations and executing CAPA implementation. Experience with validation lifecycle management and risk-based approaches. Excellent analytical and technical problem solving skills. Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.) Effective communication and interpersonal skills. Proactive with strong organization, time management, and project management abilities. Excellent attention to detail with commitment to quality and compliance. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
Employment Type
Full Time
Key Skills
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