Process Design Engineer, Irvine

Process Design Engineer

5 Days Old

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 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 a Process Design Engineer, responsible for designing, optimizing, and implementing manufacturing equipment and systems. The ideal candidate will lead technical initiatives, including Design of Experiments (DOE), and oversee the design, installation, and validation of manufacturing systems and equipment such as filling machines, packaging lines, and other process equipment.

This is a W2 Temp position with potential FTE extension.

Lead the design and optimization of pharmaceutical manufacturing process equipment and systems.
Plan and conduct experiments (DOE) to determine parameters and analyze processes, equipment, and system optimization. Ensure product quality, validate process parameters, and improve efficiency.
Collaborate with cross-functional teams including R&D, Quality, Validation, and Operations to ensure seamless product scale-up and transfer.
Develop and review engineering documentation including P&IDs, process flow diagrams, equipment specifications, and installation protocols.
Manage the technical aspects of equipment selection, procurement, installation, and commissioning.
Troubleshoot and resolve process-related issues to ensure consistent product quality and compliance.
Ensure all process designs meet cGMP, FDA, and other regulatory requirements.
Support continuous improvement initiatives to enhance manufacturing efficiency, reliability, and safety.
Additional responsibilities as required.

Requirements

Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, or related field.
5+ years of experience in process and design engineering within the pharmaceutical manufacturing industry.
Strong understanding of pharmaceutical process equipment (e.g., filling machines, mixers, reactors).
Strong knowledge of DOE methodologies and statistical analysis tools (e.g., JMP, Minitab).
Advanced knowledge of regulatory standards including cGMP, FDA, and ICH guidelines.
Experience with automation systems and process control.
Knowledge of validation protocols (IQ/OQ/PQ).
Excellent problem-solving, project management, and communication skills.
Ability to work independently and in a team-oriented environment.
Excellent attention to detail with commitment to quality and compliance.
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.

Benefits

W2 Temp positions include medical and sick time benefits.

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $95,000 - $115,000 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 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.

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Location:: Irvine
Category:: Manufacturing

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