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Validation Engineer Jobs

Company

PSC Biotech

Address , San Diego, 92101
Employment type
Salary
Expires 2023-09-12
Posted at 8 months ago
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.

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

  • Conduct preventative maintenance and perform risk assessments.
  • Develop and implement validation procedures, monitor equipment, and analyze test data.
  • Develop validation master plans and validation summary reports.
  • Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ.
  • Establish validation standards and develop performance testing and quality control measures.
  • Collaborate with multiple departments on assigned project activities and deliverables.
  • Support validation activities for CQV projects.
  • Commission, qualify, and validate equipment in assigned projects.
  • Conduct validation activities for the Keyence System (Optical Measuring) with a focus on PQ validation.
  • Recommended process improvements where needed ensuring compliance with industry standards.
  • Responsible for protocol writing and execution - Draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
  • Clearly communicate all progress, updates, and action steps for assigned projects.
  • Additional duties as assigned.


Requirements

  • Strong problem solving and analytical 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.
  • Ability to work well on a team.
  • Ability to provide proactive follow-ups and drive project completion.
  • Excellent communication skills, verbal and written.
  • Proven experience in test method validation, specifically with a strong emphasis on PQ validation of the Keyence System (Optical Measuring).
  • Minimum of 3 years of experience in validation engineering in the life science industry and cGMP environments.
  • Ability and willingness to travel is preferred.
  • Experience working at sites with aseptic environment.
  • Bachelors degree in engineering or life sciences related.
Estimated Annual Salary (based on experience): $90,000 - $115,000


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.
  • PTO, Sick Time, and Paid Holidays
  • Education Assistance
  • Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  • Pet Insurance
  • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  • Discounted rate at Anytime Fitness
  • 401(k) and 401(k) matching
  • Financial Perks and Discounts

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.

Bachelor's degree in engineering or life sciences related. Minimum of 3 years of experience in validation engineering in the life science industry and cGMP environments. Proven experience in test method validation, specifically with a strong emphasis on PQ validation of the Keyence System (Optical Measuring). Experience working at sites with aseptic environment. Excellent communication skills, verbal and written. Ability to provide proactive follow-ups and drive project completion. Ability to work well on a team. Strong problem solving and analytical skills. Ability and willingness to travel is preferred. 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.