Facilites Engineer

San Diego, United States | Posted on 09/11/2024

• Industry Pharma/Biotech/Clinical Research
• State/Province California
• Country United States

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 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 a 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.

About the Role

We are hiring a Facilities Engineer to support the onboarding of site equipment and systems, and who will be responsible for ensuring the smooth integration of new systems into existing infrastructure and supporting various engineering activities.

Responsibilities:

• Onboard Systems into CMMS (Computerized Maintenance Management System) I.e., set up system IDs, fill in system-specific details, and develop calibration and maintenance plans according to design and specification documents.
• Physically Verify System and Equipment Information to support the verification of system data (serial numbers, tag IDs, etc.) and ensure the inclusion of all necessary information.
• Support Site Engineering Team by facilitating third-party commissioning, calibration, and maintenance activities, and coordinate and oversee these tasks.
• Draft and execute IQ, OQ, PQ protocols for required equipment and systems.
• Review and approve drafted documentation to ensure compliance with regulatory standards and company policies.
• Support the team in meeting project objectives and complete all project deliverables specified in the scope.
• Support equipment, instrumentation, and calibration testing.
• Effectively collaborate with cross-functional teams to develop and implement engineering solutions that enhance efficiency, reliability, and compliance of laboratory facilities.
• Additional responsibilities as required.

Requirements

• Bachelor’s degree in a related engineering discipline.
• 3 years or more of facilities commissioning, qualification, and validation experience in the pharmaceutical industry.
• Familiarity with a CMMS such as Blue Mountain RAM, IBM Maximo, Fracttal One, or similar.
• Strong knowledge of GMP regulations and validation principles.
• Understanding of change control and deviation management.
• Technical writing skills, with strong understanding of technical validation and system documentation.
• Knowledge of hardware and equipment for automation lines is a plus.
• Strong troubleshooting, analytical, and critical thinking skills.
• Effective communication skills, with the ability to collaborate across diverse teams.
• Ability to work independently and collaboratively in a dynamic, demanding environment.
• Ability to manage multiple priorities at once to meet project deadlines.
• This position will be onsite throughout the project to facilitate completion of activities.

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 $100,000 - $120,000 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 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.