KNEAT Engineer
KNEAT Engineer
Posted on :
02-11-2023
Employer Active
1 Vacancy
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Job Description
Req ID : 2326259
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
We are hiring Validation Engineers with strong experience in KNEAT Validation.
- Lead and perform commissioning, qualification, and validation activities, ensuring compliance with regulatory requirements and industry standards.
- Execute the validation of KNEAT as the primary electronic validation and documentation system.
- Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Demonstrate proficiency in working with the KNEAT platform for efficient and effective management of validation documentation and processes.
- Generate comprehensive validation documentation, including summary reports, SOPs, validation plans, deviation/incident reports, and so on.
- Maintain accurate and up-to-date records of all validation activities.
- Conduct risk assessments and develop mitigation strategies to address identified risks.
- Work closely with cross-functional teams, including Quality Assurance, IT, and Operations, to ensure alignment on validation strategies and timelines.
- Communicate effectively with internal and external stakeholders to provide updates on validation activities.
- Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards in all validation activities.
- Additional responsibilities as required.
Requirements
- Bachelors Degree in Engineering or related.
- 3-5+ years of KNEAT Validation Engineering experience.
- Proven experience with the KNEAT platform is mandatory.
- Strong understanding of regulatory requirements and industry standards.
- Excellent communication and interpersonal skills.
- Detail-oriented with a strong ability to problem-solve and make data-driven decisions.
- Adaptable and flexible.
- Strong time-management and organizational skills.
- Travel is required. 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
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-RW1
Bachelor's Degree in Engineering or related. 3-5+ years of KNEAT Validation Engineering experience. Proven experience with the KNEAT platform is mandatory. Strong understanding of regulatory requirements and industry standards. Excellent communication and interpersonal skills. Detail-oriented with a strong ability to problem-solve and make data-driven decisions. Adaptable and flexible. Strong time-management and organizational skills. Travel is required. 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.
Employment Type
Full Time
Key Skills
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