Commissioning Qualif....
Commissioning Qualification Validation Engineer
Posted on :
28-03-2024
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Req ID : 2672463
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 AsiaPacific 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 looking for a Commissioning Qualification and Validation (CQV) Engineer. The CQV Professional would work alongside a talented PSC Biotech Team in an exciting developing and diverse biotechnology landscape.
- Commission qualify and validate GxP facilities equipment and utilities in assigned projects.
- Responsible for protocol writing and execution Draft execute review and approve validation documentation ensuring the documentation meets cGMP requirements regulatory requirements and quality standards.
- Draft and execute validation documentation such as:
- Validation Project & Master Plans
- Requirement Specifications (URS DS FS)
- IQ and OQ Test Scripts
- IQ/OQ/PQ Protocols
- Validation Summary Report
- Initiate and coordinate risk analyses design reviews and execute FAT/SAT IQ OQ and PQ.
- Conduct preventative maintenance and perform risk assessments.
- Recommended process improvements where needed ensuring compliance with industry standards.
- Establish validation standards and develop performance testing and quality control measures.
- Execute process equipment and clean room validation.
- Clearly communicate all progress updates and action steps for assigned projects. Collaborate with multiple departments on assigned project activities and deliverables.
- Additional duties as assigned.
Requirements
- Bachelors Degree in a relevant science or engineering field or equivalent years of handson experience.
- 3 years experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environment.
- Sound industry knowledge project proficiency and autonomy expected.
- Experienced in CQV of facility/utility/equipment including PW HVAC and process or laboratory equipment etc.
- Understands current riskbased validation approaches.
- Experience in authoring revising reviewing and completing controlled documents for validation projects.
- Experience with system impact assessment and risk assessment.
- Good knowledge of the code of GMP and PIC/S code.
- Previous experience in the Life Sciences Industry is required.
- Previous experience in GxP Industries are required.
- Must be adaptable customer service oriented have a positive attitude.
- Excellent organizational skills.
- High attention to detail.
- Must have strong written and verbal communication skills.
Bachelor's Degree in a relevant science or engineering field, or equivalent hands-on experience. 3+ years of experience in the biotechnology and pharmaceutical industries with a minimum of 2 years of relevant experience performing CQV activities within GMP environment. Sound industry knowledge, project proficiency, and autonomy expected. Experienced in validation of facilities/utilities/equipment, including cleaning validation and IQ/OQ/PQ of equipment. Strong understanding of current risk-based validation approaches. Experienced in authoring, revising, reviewing, and completing controlled documents for validation projects. Experienced with risk assessments. Excellent organizational skills. High attention to detail. Strong written and verbal communication skills. Strong knowledge of the code of GMP and PIC/S code. Must be adaptable, customer service oriented, and have a positive attitude. #LI-MS2
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
