CQV Engineer
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Job Location:
Monthly Salary:
Experience Required:
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 teams 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 its about more than just a jobits about your career and your future.
Your Role
We are hiring CQV Engineers to support laboratory equipment validation. Our CQV Engineers play a key role in ensuring that all systems and equipment operate reliably safely and in compliance with cGMP and regulatory standards.
- Write and execute required CQV protocols including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) for required laboratory equipment.
- Troubleshoot and resolve issues related to validated equipment and processes implementing corrective and preventive actions (CAPA) as needed.
- Prepare and maintain comprehensive documentation including validation protocols plans reports and standard operating procedures.
- Utilize risk-based approach in identifying and assessing potential risks associated with CQV activities and develop effective mitigation strategies.
- Collaborate with cross-functional teams to ensure alignment on validation activities and project timelines.
- Ensure compliance with regulatory requirements (FDA EMA etc.) and industry standards (GMP GAMP etc.).
- Additional responsibilities as assigned to drive project success.
Requirements
- Bachelors degree in Engineering (Mechanical Chemical Biomedical or related field) or Life Sciences.
- 210 years of hands-on commissioning qualification and validation experience in the pharmaceutical manufacturing industry.
- Proven experience validating laboratory equipment such as HPLCs liquid chromatography controlled temperature units etc.
- Strong technical writing skills experienced in authoring and executing IQ/OQ/PQ protocols validation reports procedures etc.
- Strong knowledge of industry standards and regulatory guidelines. Proficient in risk-based approach.
- Strong analytical and troubleshooting skills with the ability to interpret technical data and resolve equipment issues.
- Excellent written and verbal communication skills for cross-functional collaboration and documentation.
- Effective time management and organizational skills to handle multiple validation projects.
- 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.
- Must be authorized to work in the U.S
- No C2C at this time
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.
- Medical Dental and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more. - 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
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 applicants employees or interns 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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Company Industry
IT Services and IT Consulting
Key Skills
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