CQV Engineer
CQV Engineer
Posted on :
27-03-2024
Employer Active
1 Vacancy
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Jobs by Experience
3-5years
Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
27-03-2024
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 and driven Commissioning Qualification Validation (CQV) Engineer. This role will play a critical role in driving project success and executing documentation specifications design documentation and IQ OQ PQ protocols.
- Develop and execute document specifications design documentation input configuration installation qualification operational qualification and performance qualification protocols.
- Develop and execute test consumables and equipment instrumentation and calibration standards ensuring specifications/requirements and quality regulations are met.
- Draft and execute document specifications for Computer System Validation (CSV) and Software Validation.
- Provide technical writing expertise to accurately document validation processes and outcomes.
- Conduct risk analyses identifying and mitigating any potential risks or issues.
- Collaborate with crossfunctional departments to align on project tasks processes and deliverables.
- Additional responsibilities as required.
crm.templates.job.description.requirements
- Bachelors degree in related engineering discipline.
- 35 years of validation engineering experience in the pharmaceutical/life science industry including IQ OQ PQ development and execution for a range of equipment systems instrumentation and computerized systems.
- Excellent technical writing skills. Proven success in reviewing authoring and developing a range of technical documentation. This includes but is not limited to IQ OQ PQ protocols engineering specifications design documentation input configuration and so on.
- Experienced with software protocol development.
- Advanced understanding of regulatory standards and guidelines.
- Ability to produce clear and concise documentation.
- Excellent attention to detail time management and organizational skills.
- Strong analytical/problem solving skills.
- Familiarity with Information Technology (IT) and Operations Technology (OT) concepts and systems.
- Knowledge of hardware equipment and physical attributes for automation lines is a plus.
- 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.
crm.templates.job.description.benefits
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 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.
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Bachelor's degree in related engineering discipline. 3-5 years of validation engineering experience in the pharmaceutical/life science industry, including IQ, OQ, PQ development and execution for a range of equipment, systems, instrumentation, and computerized systems. Excellent technical writing skills. Proven success in reviewing, authoring, and developing a range of technical documentation. This includes but is not limited to IQ, OQ, PQ protocols, engineering specifications, design documentation, input configuration, and so on. Experienced with software protocol development. Advanced understanding of regulatory standards and guidelines. Ability to produce clear and concise documentation. Excellent attention to detail, time management, and organizational skills. Strong analytical/problem solving skills. Familiarity with Information Technology (IT) and Operations Technology (OT) concepts and systems. Knowledge of hardware, equipment, and physical attributes for automation lines is a plus. 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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