- Develop and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, utilities, and systems. Perform qualification and validation activities according to GMP regulations, company procedures, and industry standards.
- Support the installation, commissioning, qualification, and validation of equipment, systems, and production lines.
- Support the design, development, and implementation of automation solutions to improve efficiency and reliability in processes. Validate and verify automated systems to ensure functionality and compliance with regulatory requirements.
- Generate required validation documentation including protocols, master plans, summary reports, risk analyses, SOPs, verification documentation, etc.
- Provide technical support for operations, troubleshooting equipment issues, and implementing corrective actions.
- Support quality assurance activities, including deviation investigations, change control assessments, and CAPA implementation.
- Coordinate with cross-functional teams, including engineering, quality assurance, and operations, to ensure alignment and successful execution of validation activities.
- Identify and implement continuous improvement opportunities to enhance the efficiency and effectiveness of validation processes.
- Additional responsibilities as required.
- Bachelor's degree in related engineering discipline.
- 3-5+ years of commissioning, qualification, and validation experience in the pharmaceutical industry.
- Strong knowledge of regulatory standards and industry compliance.
- Proven technical skills in equipment installation, automation, and validation methodologies.
- Strong understanding of quality and risk management principles and methodologies.
- Ability to interpret technical requirements, design specifications, user requirement specifications, etc.
- Excellent technical writing skills; proven experience developing validation protocols and reports.
- Excellent problem-solving abilities and attention to detail in executing validation protocols and troubleshooting technical issues.
- 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
CQV Engineer - Richmond, 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 and driven CQV Engineer. The engineer will play a critical role in driving project success and in ensuring successful execution of commissioning, qualification, and validation for a range of equipment and systems.
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.
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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