Process Engineer (Biotech) Job Listing at Kelly Services in Alachua, FL (Job ID 9476496)

Description

Process Engineer (Biotech) | Alachua, Florida
Full-time | Long-term Contract with benefits

Kelly® Engineering is seeking a Process Engineer for a long-term engagement at one of our Global Biopharmaceutical manufacturing clients in Alachua, FL. This role is a full-time, fully benefitted position where you will be eligible for Medical, Dental, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time. 

Position Summary
The  Process Engineer will have at least 2 years of experience in GMP/GxP practices. The ideal candidate will have a background in cleanroom operations, process equipment (e.g., autoclaves, washers, bioreactors, chromatography skids), and utility systems design and maintenance. Experience in a regulated industry, such as biopharmaceuticals or medical devices, is essential.
 
Key Responsibilities

• Work as part of the Manufacturing/Process Engineering team.
• Identify opportunities for cost and time savings in production processes and utilities.
• Generate equipment layouts and utility assessments for projects.
• Address technical issues within cleanroom infrastructure and utilities.
• Oversee process and waste systems (autoclaves, washers, waste neutralization).
• Assist in complex problem-solving across functions.
• Support Quality Systems, including deviation investigations and CAPA implementation.
• Optimize cleanroom operations and infrastructure.
• Develop SOPs, work instructions, and other essential documents.
• Collaborate on design documents, technology transfers, and facility assessments.
• Draft and execute protocols for manufacturing process equipment and infrastructure.
• Support cross-functional teams, including Manufacturing, Quality Assurance, and R&D.
• Lead data analysis of process and utility systems.
• Supervise system installations and manage contractors.
• Ensure compliance with safety, health, and environmental standards.

Basic Qualifications

• Bachelor's degree
• Extensive experience as a process/critical system engineer in cGMP manufacturing within a regulated industry.
• Strong leadership and organizational skills.
• Ability to adapt to various MS&T and Engineering tasks.
• Knowledge of cGMP compliance in bioprocess drug substance manufacturing.

All applicants applying for this job opening must be legally authorized to work in the United States and are required to have US residency at the time of application. Client is not able to provide sponsorship.
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering/Technology – Project Services?

Looking to work with leading project management organizations at top companies around the world? That's where we come in. At Kelly Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world's most critical challenges. We connect you with opportunities to work on intriguing, innovative, and high-visibility projects—all with a schedule that works for you. Do you prefer the variety and flexibility of short-term projects? Or are looking for a long-term opportunity? Either way, our connections and expertise will help you take your career exactly where you want to go. That's just good planning.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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