CQV Engineer III
Posted on :
14-02-2024
Employer Active
1 Vacancy
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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 a CQV Engineer III to support the commissioning qualification and validation of a new facility build out including facilities utilities manufacturing warehousing and laboratory design construction and CQV testing.
- Lead the development and execution of all required CQV testing.
- Develop and execute design qualification installation operational qualification functional risk assessment data integrity assessment traceability matrix and performance qualification for all required equipment utilities and systems.
- Participate in design reviews and provide input to ensure that CQV requirements are considered in the early stages.
- Support all utilities CQV testing including but not limited to process water clean in place solution storage and distribution nitrogen generation compressed air generation and waste neutralization as well as chillers boilers compressors tanks and electrical utilities.
- Central Utilities Plant (CUP): support utilities including chillers boilers compressors and electrical.
- Execute the CQV testing for required HVAC systems. HVAC systems supply classified and controllednotclassified (CNC) manufacturing areas (including airlocks and corridors) warehouse cold storage laboratory and general nonclassified maintenance and office areas.
- Utilities: process water (PW) generation/distribution cleaninplace (CIP) solution storage/distribution nitrogen generation/distribution argon generation/distribution compressed air generation/distribution and waste neutralization.
- Support the warehouse and laboratory commissioning qualification and validation.
- Develop and maintain comprehensive documentation including CQV plans protocols reports and standard operating procedures (SOPs).
- Support and execute all required temperature mapping requirements.
- Conduct risk assessments and impact analyses to identify and address potential issues during the commissioning and qualification phases.
- Troubleshoot and resolve issues related to CQV activities working closely with relevant stakeholders to implement corrective actions.
- Collaborate with crossfunctional teams including engineering quality and operations to ensure alignment of CQV activities with project timelines and goals.
- Additional responsibilities as required.
Requirements
- Bachelor s Degree in relevant engineering discipline.
- 612 years of experience in commissioning qualification and validation of facilities utilities equipment and systems withing cGMP regulated industries.
- Indepth knowledge of cGMP regulations international standards and industry best practices.
- Excellent technical writing skills.
- Strong analytical and problemsolving skills with the ability to make sound decisions based on data and risk assessments.
- Excellent communication and interpersonal skills with the ability to effectively collaborate with multidisciplinary teams and stakeholders.
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 Base Salary (dependent on experience) $125000 $175000.
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.
Bachelor s Degree in relevant engineering discipline. 6-12 years of experience in commissioning, qualification, and validation of facilities, utilities, equipment, and systems withing cGMP regulated industries. In-depth knowledge of cGMP regulations, international standards, and industry best practices. Excellent technical writing skills. Strong analytical and problem-solving skills, with the ability to make sound decisions based on data and risk assessments. Excellent communication and interpersonal skills, with the ability to effectively collaborate with multidisciplinary teams and stakeholders.
Employment Type
Full Time
Key Skills
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