- Support the review and generation of validation protocols and reports including equipment IQ, OQ, PQ protocols.
- Contribute to preparing technical documentation including protocols, test reports, summary reports, etc. and maintain accurate records of all validation activities.
- Support equipment validation field execution according to established test plans, ensuring adherence to quality standards and regulatory requirements.
- Collaborate with cross functional teams to align on validation activities and deliverables.
- Assist in investigations and risk assessments to support mitigation and improvement strategies.
- Ensure compliance with relevant industry standards, regulations, and best practices.
- Additional responsibilities as required.
- Bachelor's degree in relevant engineering discipline.
- At least 1 year of experience through internships or other professional experiences in supporting equipment validation execution. Experience in pharmaceutical manufacturing environments is a plus.
- Strong understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
- Excellent technical writing skills, both hand-written and electronically.
- Strong analytic and problem solving skills.
- Excellent attention to detail and accuracy.
- Effective communication and interpersonal skills.
- Strong continuous learning mindset.
- Familiar with validation techniques and testing methods.
- 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 Project Engineer I - La Verne, 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
We are hiring an entry-level Validation Engineer. Candidates should have prior experience whether through internships or other related professional experience supporting validation execution and GDP/GMP technical documentation.
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.
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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