- Responsible for executing risk assessment and FMEA for assigned products, processes, and various equipment and systems.
- Analyze processes, identify risks, causes, and effects, and provide efficient solutions to any potential failures.
- Initiates, authors, revises, reviews, and completes all required validation documentation.
- Generate, prepare and execute protocols, analyze test results, and prepare technical reports with little supervision.
- Contribute directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports.
- Support the review and qualification of equipment for commissioning, qualification, and validation activities.
- Collaborate with multiple departments on assigned project activities and deliverables.
- Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ.
- Additional duties and responsibilities as assigned.
- Bachelor's Degree in Engineering or related.
- 5-8 years of validation experience in an aseptic environment.
- Strong knowledge and experience with risk assessment processes and FMEA.
- Experience in authoring and executing validation documentation.
- Experience in developing SOPS, final reports, and validation/quality policies.
- Experience in equipment and process qualification for compounding, filling, assembly, etc.
- Strong understanding of developing, executing, and maintaining CQV procedures and policies.
- Advanced understanding of cGMP guidelines.
- Ability to work independently with limited supervision.
- Excellent communication skills.
- Strong organization skills and attention to detail.
- Analytical and problem solving skills.
- 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.
- 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
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Validation Engineer - Fort Worth, United States - PSC Biotech
Description
Job DescriptionPSC 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
Offering a full suite of benefits, PSC BiotechTM 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.
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.
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