Project Engineer

Los Angeles, CA - USA

Monthly Salary: USD 100000 - 110000

Posted on: 30+ days 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 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

We are hiring a motivated Project Engineer with direct experience in ensuring adherence to regulatory requirements including EU GMP Annex 1 FDA 21 CRF and ISO guidelines. This role verifies cleanroom and controlled environment qualifications meet GMP and regulatory standards. This hands-on position requires strong leadership cross-functional collaboration and a deep understanding of testing protocols. Youll be responsible for coordinating and executing testing activities guiding teams through dynamic room testing and ensuring all documentation aligns with Annex 1 and internal quality expectations.

Oversee the planning and execution of room qualification testing ensuring alignment with production schedules and regulatory requirements.
Act as a central point of contact between manufacturing engineering quality and external labs to facilitate smooth testing operations.
Maintain adherence to Annex 1 standards through proper documentation signage and procedural controls during testing.
Create and manage qualification protocols and reports using established templates ensuring clarity and consistency.
Identify and respond to deviations during testing contributing to root cause analysis and corrective actions.
Apply environmental monitoring systems and particle counting technologies to support data collection and analysis.
Contribute to facility qualification and requalification efforts ensuring environments are compliant ahead of audits and inspections
Additional Responsibilities as assigned.

Requirements

Bachelors degree in a scientific engineering or technical discipline (e.g. Life Sciences Engineering or related field)
5-10 years of experience within the GMP regulated pharmaceutical and/or biopharmaceutical industry with direct experience in executing room qualification environmental monitoring and aseptic/sterile procedures.
Demonstrated ability to lead testing teams and coordinate activities across departments
Advanced knowledge in Annex 1 requirements and cleanroom classification standards.
Strong understanding of room readiness signage requirements etc.
Experience writing and executing qualification protocols (IQ/OQ/PQ).
Proficiency with testing tools and procedures such as Climet particle counters HEPA filter integrity testing equipment and EMS systems.
Strong organizational skills with the ability to manage schedules personnel and documentation simultaneously.
Excellent communication and collaboration skills.
Strong analytical and problem-solving skills.

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 $90000 - $115000 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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