The Role
Leads engineering projects in regulated life sciences manufacturing from requirements and design through procurement, installation, commissioning, qualification, and closeout. Coordinates Manufacturing, Quality, Validation, Automation, Facilities, EHS, contractors, and vendors while managing scope, schedules, budgets, documentation, GMP compliance, change control, risk, and safety. Supports equipment startup, troubleshooting, operational readiness, system turnover, and improvements to reliability, efficiency, compliance, and project execution.
Summary Generated by Built In
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 decide 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 an experienced Project Engineer who will support the planning, design, execution, and delivery of engineering projects within a regulated life sciences manufacturing environment. The Project Engineer will coordinate cross-functional activities associated with facility, utility, manufacturing equipment, laboratory, and infrastructure projects while ensuring alignment with GMP requirements, quality standards, safety expectations, project schedules, and approved budgets.
The ideal candidate will bring hands-on engineering project experience within the pharmaceutical, biotechnology, biologics, or other regulated life sciences industry and be comfortable working across Engineering, Manufacturing, Quality, Validation, Automation, Facilities, EHS, and external vendors.
- Lead and support engineering projects from concept and requirements definition through design, procurement, installation, commissioning, qualification, and project closeout.
- Develop project scopes, schedules, budgets, resource plans, and implementation strategies.
- Coordinate engineering activities involving manufacturing equipment, clean utilities, facilities, laboratories, automation, and supporting infrastructure.
- Develop and/or review engineering documentation, including:
- User Requirements Specifications (URS)
- Design specifications and drawings
- Equipment specifications
- Engineering assessments
- Vendor documentation
- Commissioning and qualification documentation
- Turnover and closeout packages
- Ensure engineering projects are executed in accordance with applicable GMP requirements, site quality systems, engineering standards, and EHS requirements.
- Partner with Quality and Validation teams to ensure appropriate commissioning, qualification, validation, and change control activities are incorporated into project execution.
- Support a risk-based approach to project planning, equipment implementation, and qualification activities.
- Coordinate equipment installation, field activities, construction contractors, equipment vendors, and engineering service providers.
- Review vendor proposals, technical specifications, drawings, submittals, and equipment documentation for compliance with project requirements.
- Facilitate design reviews, project meetings, risk assessments, and technical troubleshooting sessions.
- Monitor project performance against scope, schedule, budget, quality, and safety objectives and proactively address project risks or issues.
- Manage engineering changes through established change control and document control processes.
- Support equipment startup, commissioning, troubleshooting, and operational readiness activities.
- Coordinate turnover of completed systems and equipment to Manufacturing, Facilities, Maintenance, and other system owners.
- Maintain clear project documentation and provide regular status updates to project stakeholders and leadership.
- Identify opportunities to improve equipment reliability, operational efficiency, compliance, and project execution.
Requirements
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Biochemical Engineering, or another relevant engineering discipline.
- 5+ years experience within pharmaceutical, biotechnology, biologics, cell and gene therapy, medical device, or other FDA-regulated manufacturing environments.
- Demonstrated experience managing or executing engineering projects in a GMP-regulated facility.
- Working knowledge of engineering project lifecycle activities, including design, procurement, installation, commissioning, qualification, and turnover.
- Experience working with cross-functional groups such as Manufacturing, Quality Assurance, Validation, Automation, Facilities, Maintenance, and EHS.
- Understanding of GMP documentation practices, change control, deviations, CAPA, and controlled engineering documentation.
- Experience coordinating vendors, contractors, and engineering firms.
- Strong project management, organization, communication, and problem-solving skills.
- Ability to manage multiple priorities and work effectively in a fast-paced manufacturing environment.
- Must be authorized to work in the U.S.
- No C2C at this time.
Preferred Qualifications
- Experience supporting biopharmaceutical or biologics manufacturing facilities.
- Experience with process equipment and systems such as bioreactors, chromatography systems, filtration systems, CIP/SIP equipment, single-use technologies, or associated manufacturing equipment.
- Experience with clean utilities, including purified water/WFI, clean steam, process gasses, HVAC, and controlled manufacturing environments.
- Familiarity with commissioning and qualification (C&Q) practices and risk-based qualification approaches.
- Knowledge of applicable regulations and industry guidance, including FDA cGMP, 21 CFR Parts 210/211, ISPE guidance, and GAMP principles, as applicable to assigned projects.
- Experience supporting capital projects, facility expansions, equipment upgrades, technology transfers, or manufacturing capacity expansion.
- Project management certification or formal project management training is a plus.
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
- Fitness Perks and Discounted Rates
- Financial Perks and Discounts
The salary range for this role is set between $100,000 - $120,000. The salary offered 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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Skills Required
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Biochemical Engineering, or a relevant engineering discipline
- 5+ years of experience in pharmaceutical, biotechnology, biologics, cell and gene therapy, medical device, or other FDA-regulated manufacturing environments
- Experience managing or executing engineering projects in a GMP-regulated facility
- Working knowledge of engineering project lifecycle activities, including design, procurement, installation, commissioning, qualification, and turnover
- Experience working with Manufacturing, Quality Assurance, Validation, Automation, Facilities, Maintenance, and EHS teams
- Understanding of GMP documentation practices, change control, deviations, CAPA, and controlled engineering documentation
- Experience coordinating vendors, contractors, and engineering firms
- Strong project management, organization, communication, and problem-solving skills
- Ability to manage multiple priorities in a fast-paced manufacturing environment
- Must be authorized to work in the United States
- Experience supporting biopharmaceutical or biologics manufacturing facilities
- Experience with bioreactors, chromatography systems, filtration systems, CIP/SIP equipment, single-use technologies, or related manufacturing equipment
- Experience with clean utilities, including purified water/WFI, clean steam, process gases, HVAC, and controlled manufacturing environments
- Familiarity with commissioning and qualification practices and risk-based qualification approaches
- Knowledge of FDA cGMP, 21 CFR Parts 210/211, ISPE guidance, and GAMP principles
- Experience supporting capital projects, facility expansions, equipment upgrades, technology transfers, or manufacturing capacity expansions
- Project management certification or formal project management training
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
