- Develop and write comprehensive validation protocols and plans ensuring compliance with industry regulations.
- Write, review, and execute IQ, OQ, PQ protocols for a range of equipment and systems including but not limited to vial washers, depyrogentation tunnels, isolators, and sterile fillers.
- Write and generate validation documentation including protocols, exceptions, summary reports, master plans, etc.
- Perform risk assessment, analyze qualification data and acceptance criteria, and identify potential validation issues. Implement efficient mitigation strategies.
- Implement risk-based approaches to validation to optimize efficiency.
- Analyze validation data, prepare reports, and provide recommendations for continuous improvement.
- Collaborate closely with cross functional teams to schedule required validation and qualification activities.
- Maintain accurate and detailed documentation updates throughout the validation lifecycle, including SOPs, forms, reports, etc.
- Attend required project meetings.
- Additional responsibilities as required in order to drive project success.
- Bachelor's degree in related engineering discipline.
- 5+ years of experience as a Validation Engineer within the pharmaceutical manufacturing industry/aseptic fill manufacturing environment.
- Advanced experience developing and reviewing technical validation documentation including IQ, OQ, PQ protocols, summary reports, and so on.
- Strong understanding of regulatory requirements.
- Direct and proven experience executing the validation and qualification for a range of equipment.
- Direct experience executing IQ/OQ/PQ for vial washers, depyrogentation tunnels, isolators, and sterile fillers.
- Excellent analytical and problem-solving skills. Ability to troubleshoot effectively.
- Excellent communication skills and interpersonal skills.
- Detail-oriented mindset with a commitment to maintaining high-quality standards.
- 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 - Pomona, United States - PSC Biotech
Description
Job 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
We are hiring an experienced Validation Engineer to join our team in Pomona, CA. Candidates should have extensive technical writing experience as well as the review and execution of validation protocols. Equipment experience should include vial washers, depyrogentation tunnels, isolators, and sterile fillers.
Requirements
BenefitsOffering 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.
Estimated annual salary (dependent on experience) $85,000 - $95,000
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.
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