CSV Engineer

Job Description
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.

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together to form something truly special. When you decide 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:

• Responsible for performing the validation of equipment, clean rooms, fill lines, utility systems, facilities, processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision, preparing protocols independently, analyzing test results, and preparing technical reports.
• Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
• Coordinates validation activities with, and seeks team support from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget.
• Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work.
• Reviews protocols, reports and data tables generated by peers and contract personnel.Represents the department on cross-functional project teams.

Requirements

• Bachelor's degree from accredited institution in Science or Engineering
• 2+ years of experience in Pharma or regulated industry
• Strong background and experience in Validation and GMP regulations.
• GAMP Experience
• Aseptic Fill Line Experience
• Proven knowledge of regulatory requirements and industry standards (cGMP, FDA, etc.).
• Strong understanding of risk-based validation approach.
• Proactive and motivated with the ability to manage multiple tasks /projects.
• Excellent problem-solving, analytical, and technical skills.
• Strong time management and organizational abilities.
• Effective communication and interpersonal skills.
• Detail-oriented mindset with a commitment to maintaining high-quality standards.
• Ability to work independently and as part of a team.

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 Holiday
• Education Assistance
• Pet Insurance
• Discounted Fitness/Gym Rates
• Financial Perks and Discounts

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 - $110,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

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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