CQV Engineer
Posted on :
06-12-2023
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
06-12-2023
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 motivated and experienced Commissioing Qualification Validation (CQV) Engineers at all levels of experience junior to senior level (minimum of 3 years). As a CQV Engineer you will play a crucial role in ensuring the successful commissioning qualification and validation of equipment systems and processes. Candidates should have a strong background in CQV within the pharmaceutical manufacturing industry a deep understanding of regulatory requirements and the ability to work collaboratively with crossfunctional teams.
- Support all CQV activities and develop and implement comprehensive validation plans.
- Develop and execute CQV protocols for required equipment facilities utilities systems and processes ensuring compliance with regulatory requirements and industry standards.
- Write review and approve technical CQV documentation including standard operating procedures validation plans execution plans risk assessments summary reports URS FRS design specifications testing protocols and so on.
- Conduct risk assessments to identify and mitigate potential validation risks.
- Support investigations deviations and change control processes. Assess the impact of changes to processes equipment and systems and ensure appropriate validation activities are conducted in accordance with change control procedures.
- Work closely with crossfunctional teams including engineering manufacturing quality assurance and regulatory affairs to ensure seamless integration of CQV activities.
- Recommended process improvements where needed ensuring compliance with industry standards.
- Additional responsibilities as assigned.
Requirements
- Bachelors Degree in Engineering.
- Hiring at all levels junior to senior CQV Engineers with a minimum of 3 years of experience.
- Proven handson experience in commissioning qualification and validation in the life sciences/pharmaceutical industry.
- Experienced in executing CQV protocols for a wide variety of equipment facilities utilities systems and processes.
- Strong knowledge of regulatory requirements and industry standards (cGMP GDP FDA EMA etc.)
- Strong analytical and problemsolving skills with a meticulous attention to detail.
- Excellent communication and interpersonal skills.
- Ability to work independently and collaboratively in a fastpaced environment.
- 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
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 Engineering. Hiring at all levels, junior to senior CQV Engineers with a minimum of 3 years of experience. Proven hands-on experience in commissioning, qualification, and validation in the life sciences/pharmaceutical industry. Experienced in executing CQV protocols for a wide variety of equipment, facilities, utilities, systems, and processes. Strong knowledge of regulatory requirements and industry standards (cGMP, GDP, FDA, EMA, etc.) Strong analytical and problem-solving skills, with a meticulous attention to detail. Excellent communication and interpersonal skills. Ability to work independently and collaboratively in a fast-paced environment. 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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