- Drive overall continuous improvement processes, leading efforts within GxP laboratory for facilities engineering, utilities, and automation.
- Conduct thorough assessments of laboratory facilities, identifying areas for improvement and implementing strategic action plans to address potential issues.
- Develop, update, and manage controlled documentation including but not limited to procedures development, compliance records, etc.
- Ensure ongoing compliance with industry regulations and internal requirements, this includes leading compliance management, change controls, deviations and CAPA management, and engineering supplier qualifications.
- Identify and implement continuous improvement strategies for facilities and utilities systems such as environmental monitoring systems.
- Lead site security management efforts to include managing work orders and maintaining the computerized maintenance management system.
- Effectively collaborate with cross-functional teams to develop and implement engineering solutions that enhance the efficiency, reliability, and compliance of laboratory facilities.
- Additional responsibilities as required.
- Bachelor's degree in related engineering or STEM discipline.
- At least 2 years of experience in an engineering role within GxP environments.
- Experience supporting GxP and GMP laboratories is preferred.
- Experienced supporting routine engineering tasks within clean rooms and cleaning programs.
- Experienced with gas systems.
- Experience driving quality and compliance management (i.e. CAPA management, deviation investigations, change control management, etc.)
- Experienced with supplier qualification.
- Proven success in driving continuous improvement processes.
- Strong knowledge of technical and controlled documentation.
- System experience in TrackWise, Veeva Systems, SAP PM, access management systems, and Environmental Monitoring systems is preferred.
- Strong understanding of regulatory requirements, including FDA regulations, cGMP, GxP, GLP, GDP, etc.
- Excellent communication and interpersonal skills.
- Ability to work independently and collaboratively in a dynamic, fast-paced environment.
- Strong problem solving and analytical skills.
- Detail oriented and quality focused mindset.
- Adaptable and flexible.
- 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.
- 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
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Facilities Engineer - Pasadena, United States - PSC Biotech
Description
Job Description
Job DescriptionPSC 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 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 a motivated and experienced Facilities Engineer. The Facilities Engineer will play a critical role in leading engineering tasks and improvement efforts, and should possess a strong background in GxP environments.
Requirements
BenefitsOffering a full suite of benefits, PSC BiotechTM 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.
Estimated Annual Base Salary (dependent on experience) $80,000 to $100,000.
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.
