Validation Engineer

Irvine, CA - USA

Monthly Salary: USD 75 - 125

Experience Required: 10years

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

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 teams 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 its about more than just a jobits about your career and your future.

Your Role

Our Validation Engineers support the full CQV lifecycle ensuring facilities utilities equipment computerized systems and manufacturing processes are designed installed operated and maintained in compliance with FDA EU and global GxP regulations. This role plays a critical part in reducing compliance risks and enhancing operational performance while executing high-quality validation deliverables providing technical expertise and supporting regulatory readiness.

Responsible for the planning commissioning qualification and validation activities for required cGMP manufacturing and lab equipment utilities and computerized systems.
Author review and execute validation deliverables including but not limited to validation plans design specifications user requirement specifications risk assessments DQ IQ OQ PQ generation and testing summary and final reporting.
Perform system readiness assessments and verification testing.
Ensure systems meet user requirements functional specifications and data integrity expectations.
Manage system implementation activities including configuration backup/restore and periodic reviews.
Write review and approve SOPs; ensure documentation is accurate traceable audit-ready and compliant.
Participate in deviation investigations root cause analysis and support CAPA implementation and change control processes.
Provide user training and ongoing technical support.
Collaborate with cross-functional teams to align on technical functions deliverables and quality events.
Additional responsibilities as required to drive project success.

Requirements

Bachelors degree in engineering or related technical discipline.
310 years of experience in validation within GMP-regulated environments (pharmaceutical or biotech).
Hands-on experience validating GxP manufacturing and lab based equipment analytical instruments and associated computerized systems.
Strong understanding of full lifecycle validation and risk-based approach.
Well-versed in regulatory requirements and guidelines (FDA EMA ICH cGMP GAMP 5 21 CFR Part 11 EU Annex 11).
Experienced with traceability change control deviation handling and CAPA management.
Strong technical writing and documentation skills.
Excellent attention to detail problem-solving and analytical skills.
Ability to manage multiple projects and timelines.
Willingness to travel as needed for project assignments and client engagements.
Must be authorized to work in the US.
No C2C at this time.

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 Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts

Adhering to the requirements of Californias law on salary transparency the salary bracket for this role is set between $75000 - $125000 annually. The salary offered may be adjusted based on various factors such as the applicants 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 applicants employees or interns 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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Required Skills:

57 years of handson SAP PM/EAM experience. Deep knowledge of Blue Mountain RAM and its application in regulated environments. Proven ability to manage asset lifecycle processes calibration scheduling and equipment revalidation. Strong documentation skills and familiarity with compliance frameworks (GxP 21 CFR Part 11 CSV/CSA). Excellent communication and stakeholder engagement skills. Bachelors degree in Engineering Information Systems or related field (advanced certifications a plus).