Validation Engineer
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
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 teams 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 its about more than just a jobits about your career and your future.
Your Role
We are hiring an experienced Validation Engineer to support equipment process and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably safely and in compliance with cGMP and regulatory standards. This role involves planning writing implementing and executing validation protocols to ensure consistent product quality and regulatory compliance.
- Perform validation of PLC logic and operational sequences across normal abnormal and emergency scenarios.
- Conduct endtoend testing of SCADA system integrations ensuring accurate process visualization trending and operator control functionality.
- Execute realtime testing of sitewide system interactions including signal communication between PLCs SCADA platforms and auxiliary equipment.
- Verify data logging capabilities and integration with the PI Historian to support batch reporting audit trails and regulatory compliance documentation.
- Assess network resilience by testing system redundancy communication failover and implementation of security and accesscontrol protocols.
- Ensure seamless integration and validation of manufacturing equipment and facility systems.
- Troubleshoot and resolve issues related to validated equipment and processes implementing corrective and preventive actions (CAPA) as needed.
- Additional responsibilities as assigned to drive project success.
Requirements
- Bachelors degree in Engineering (Mechanical Chemical or related field) or Life Sciences
- 25 years of validation experience within the pharmaceutical biotech or medical device industries
- Strong knowledge of equipment and process validation in FDA-regulated environments
- Familiarity with industry standards such as ASTM E2500 ISPE Baseline Guides and cGMP regulations
- Experience with cleanroom systems HVAC purified water compressed air and other critical utilities
- Proficiency in writing and executing IQ/OQ/PQ protocols and validation reports
- Strong analytical and problem-solving skills
- Excellent written and verbal communication abilities
- Strong time management and organizational skills
- Detail-oriented mindset with a commitment to maintaining high-quality standards
- Must be authorized to work in the US
- No C2C at this time
Benefits
W2 positions include our medical and sick time benefits.
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 applicants employees or interns 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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Company Industry
IT Services and IT Consulting
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
