CSV Professional
CSV Professional
Posted on :
23-10-2024
Employer Active
1 Vacancy
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Jobs by Experience
3-5years
Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
23-10-2024
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 looking for a Computer System Validation Professional. This role would work alongside an amazingly talented PSC Team and works under the leadership of one of the best in the industry!
Successful candidates will have excellent verbal and written communication skills an understanding of the IT realm and a thirst to learn!
- Keep up to date with advances in the field and the regulatory requirements.
- Maintain comprehensive knowledge of ACE features.
- Maintain comprehensive knowledge of Katalon/Selenium automated software testing tools.
- Author review approve revise and execute computer system validation (CSV) deliverables and ensure they meet regulatory requirements and quality standards.
- Author review revise and approve data migration documents and perform random sampling to ensure statistical confidence levels in the data migrated into or exported from ACE.
- Create revise execute and review Katalon/Selenium automated tests for ACE workflows.
- Prioritize ACE Enterprise implementation work for customers but also assist with validation of core ACE functionality (IOQ) ACE Essentials BioTechnique and other internal projects.
- Author and revise SOPs and training materials as needed.
- Provide estimated validation hours for projects.
- Provide guidance for validation deliverables and strategies.
- Additional duties and responsibilities may be assigned from timetotime.
Requirements
- Bachelors Degree in Computer Science or related field.
- Must have strong written and verbal communication skills.
- Previous experience with Katalon/Selenium is preferred.
- Previous experience in the IT industry is preferred.
- Previous experience in Pharma Life Science GxP industries is preferred.
- Must be adaptable customer service oriented have a positive attitude.
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.
#LIFF1
Bachelor s Degree in Engineering. 3-5 years of applicable work experience in commissioning, qualifying and validating facilities, equipment, and utilities within the pharmaceutical manufacturing industry or related. Strong understanding of regulatory requirements (FDA, EU, etc.) and industry standards (GMP, ISO, CFR21, etc.). KNEAT validation experience and/or certification is preferred. Hands-on experience with commissioning, qualification, and validation protocols, execution, and documentation including SOPs, final reports, master plans, etc. Proficiency in risk assessment methodologies and tools. Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents. Detail-oriented with a strong commitment to quality and compliance. Excellent analytical and problem-solving skills. Strong communication skills, verbal and written. 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-FF1
Employment Type
Full Time
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