Process Engineer

Job Description

Job Description

Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Our Purpose

We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally :

• We act with integrity
• We serve each other
• We serve society
• We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Job Summary :

We are seeking motivated Aseptic Process Engineers and Aseptic Validation Engineers to join our team.

In this role, you will support biotech and pharmaceutical projects across the country, focusing on commissioning, qualification, validation, and aseptic process engineering. These are full-time opportunities with competitive compensation and benefits, including retirement contribution, generous PTO, health insurance, professional education support, and more. Travel will be required, primarily within the U.S., with occasional international assignments.

Key Responsibilities :

o   Design, operate, install, troubleshoot, commission, and qualify cGMP manufacturing process activities within isolators or biosafety cabinets.

o   Support sterile operations including vial, prefilled syringe, and cartridge filling lines.

o   Contribute to pilot and commercial scale bioreactors, centrifugation, chromatography skids, ultrafiltration / diafiltration, depth filtration, and lyophilization / freeze drying processes.

o   Work with automated visual inspection systems, automated formulation systems, autoclaves, and CIP / SIP systems.

o   Assist in developing validation / verification master plans, commissioning plans, and qualification protocols.

o   Perform formal risk assessments (e.g., FMEA) and identify critical attributes and process parameters.

o   Develop and maintain project plans, schedules, and issue tracking for client projects.

o   Ensure compliance with regulatory requirements, industry standards, and company quality expectations.

Qualifications :

o   BS or MS in a relevant engineering or science field, or equivalent experience.

o   Three (3) or more years of experience in aseptic process engineering or validation in biotech or pharmaceutical industries.

o   Excellent oral and written communication skills in English.

o   Team-oriented, customer-service focused, and able to collaborate effectively with cross-functional teams.

o   Ability to travel domestically and internationally as required.

o   Ability to work (paid) overtime as needed.

o   Eligible to work in the U.S. without sponsorship now or in the future.

Preferred Skills :

o   Experience with commissioning and qualification projects in regulated industries.

o   Background in developing user requirements, risk assessments, and traceability matrices.

o   Proficiency in project management including planning, estimating, scheduling, and issue resolution.

o   Familiarity with regulatory and industry standards for aseptic processes and validation.

1. Aseptic & cGMP Process Support

o  Design, operate, troubleshoot, and qualify aseptic / cGMP manufacturing processes.

o  Support sterile operations (vial, syringe, cartridge filling lines).

o  Work with bioreactors, centrifugation, chromatography skids, and filtration systems.

2. Equipment & Systems

o  Support lyophilization / freeze drying, automated inspection and formulation systems.

o  Operate and qualify autoclaves, Clean-in-Place (CIP), and Steam-in-Place (SIP) systems.

3. Validation & Risk Management

o  Develop validation / verification master plans and qualification protocols.

o  Perform risk assessments (e.g., FMEA) and define critical attributes / process parameters.

4. Project Management & Compliance

o  Develop and maintain project plans, schedules, and issue tracking.

o  Ensure compliance with regulatory requirements, industry standards, and quality expectations.

#LI-MV1

Average base salary range - not including benefits or cost of living adjustment.

CAI Benefits :

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.