Job DescriptionYour RoleWe 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.
BenefitsOffering 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.
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