Validation Engineer
3 weeks ago
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
We are hiring skilled Validation Engineers to join our team Candidates should have experience in both Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering. Our Engineers will play a crucial role in ensuring that our processes, equipment, and computerized systems meet regulatory requirements and industry standards. This is a remote position supporting the schedule of M-F 8pm - 5am PH.
- Develop and execute commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
- Execute computer system validation activities, including defining user requirements, developing test scripts, and conducting validation testing.
- Collaborate with cross-functional teams to ensure that systems and processes meet regulatory and quality standards.
- Perform risk assessments and develop validation plans to mitigate potential risks.
- Generate and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs).
- Participate in change control processes to assess the impact of changes on validated systems.
- Investigate and resolve deviations related to validation activities, ensuring compliance with regulatory requirements.
- Proactively identify opportunities for process improvements in validation activities.
- Stay abreast of industry trends, regulatory changes, and best practices related to CQV and CSV.
- Additional responsibilities as required.
Requirements
- Bachelor's degree in Engineering or related technical field.
- Minimum of 3-5 years of validation engineering experience in the pharmaceutical industry.
- Demonstrated experience in both Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering.
- Strong technical writing and documentation skills.
- Strong understanding of regulatory requirements, Data Integrity, 21 CFR Part 11 Compliance, GAMP 1-4 or 5.
- Experience with risk-based validation approaches and methodologies.
- Excellent analytical and problem-solving skills.
- Effective communication and interpersonal skills.
- Detail-oriented with strong organizational abilities.
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.
#LI-FF1
Requirements
Bachelor's degree in Engineering or related technical field. Minimum of 3-5 years of validation engineering experience in the pharmaceutical industry. Demonstrated experience in both Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering. Strong technical writing and documentation skills. Strong understanding of regulatory requirements, Data Integrity, 21 CFR Part 11 Compliance, GAMP 1-4 or 5. Experience with risk-based validation approaches and methodologies. Excellent analytical and problem-solving skills. Effective communication and interpersonal skills. Detail-oriented with strong organizational abilities. 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. #LI-FF1
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