Senior CQV Engineer
Senior CQV Engineer
Posted on :
31-05-2025
Employer Active
1 Vacancy
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Jobs by Experience
7years
Monthly Salary
100000 - 130000
Vacancy
1 Vacancy
Posted on :
31-05-2025
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 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
As a Senior CQV Engineer you will spearhead commissioning qualification and validation efforts for pharmaceutical facilities utilities equipment and systems. In this role youll take the lead in project planning execution and ensuring operational readiness of capital projects contributing directly to our clients success.
Key responsibilities include:
- Managing project priorities schedules and budgets while proactively addressing risks and challenges.
- Designing and implementing CQV protocols for equipment and systems to meet compliance and performance standards.
- Creating and maintaining thorough documentation including validation protocols plans reports and SOPs.
- Assessing and mitigating risks associated with CQV processes.
- Diagnosing and resolving issues related to equipment and process functionality.
- Collaborating with cross-functional teams to streamline CQV activities and maintain alignment with project goals.
- Acting as a key liaison between vendors and contractors ensuring seamless transitions and hand-offs.
- Upholding compliance with regulatory bodies (FDA EMA etc.) and industry standards (GMP GAMP etc.).
- Providing technical expertise and ongoing support throughout validation and qualification phases.
- Taking on additional duties as needed to support project success.
Requirements
- Bachelor s degree in engineering or a related discipline.
- At least 7 years of CQV experience in the pharmaceutical or biotech sector.
- Hands-on knowledge of laboratory equipment including freezers refrigerators water generation skids and scales.
- Expertise in validating aseptic environments temperature-controlled units and environmental monitoring performance qualifications.
- Background in CQV processes for facilities and utilities such as air compressors boilers chillers clean steam generators WFI and HVAC systems.
- Demonstrated success in leading CQV projects with experience managing schedules resources and budgets.
- Deep understanding of regulatory compliance and industry best practices.
- Skilled in validation lifecycle management and risk-based methodologies.
- Proficient in CQV project lifecycle execution from initiation through closeout.
- Strong analytical and problem-solving abilities with a strategic approach to risk resolution.
- Excellent technical writing skills with knowledge of documentation requirements including protocols reports risk assessments and specifications.
- Effective communicator and collaborator with experience managing stakeholder interactions.
- Highly organized and proactive in driving tasks forward.
- Detail-oriented with an unwavering 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
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
- Estimated annual salary (dependent on experience) $100000 $130000
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-RD1
Bachelor s degree in engineering or a related discipline. At least 7 years of CQV experience in the pharmaceutical or biotech sector. Hands-on knowledge of laboratory equipment, including freezers, refrigerators, water generation skids, and scales. Expertise in validating aseptic environments, temperature-controlled units, and environmental monitoring performance qualifications. Background in CQV processes for facilities and utilities such as air compressors, boilers, chillers, clean steam generators, WFI, and HVAC systems. Demonstrated success in leading CQV projects, with experience managing schedules, resources, and budgets. Deep understanding of regulatory compliance and industry best practices. Skilled in validation lifecycle management and risk-based methodologies. Proficient in CQV project lifecycle execution, from initiation through closeout. Strong analytical and problem-solving abilities, with a strategic approach to risk resolution. Excellent technical writing skills with knowledge of documentation requirements, including protocols, reports, risk assessments, and specifications. Effective communicator and collaborator, with experience managing stakeholder interactions. Highly organized and proactive in driving tasks forward. Detail-oriented with an unwavering 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.
Education
Bachelor s degree in engineering or a related discipline.
Employment Type
Full Time
Key Skills
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