Process Engineer
Process Engineer
Posted on :
27-09-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
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 weve challenged ourselves to do what others wouldnt. 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 isnt simply a goal. Its 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. Were not interested in how it used to be done. Were 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
oDesign operate troubleshoot and qualify aseptic/cGMP manufacturing processes.
oSupport sterile operations (vial syringe cartridge filling lines).
oWork with bioreactors centrifugation chromatography skids and filtration systems.
2. Equipment & Systems
oSupport lyophilization/freeze drying automated inspection and formulation systems.
oOperate and qualify autoclaves Clean-in-Place (CIP) and Steam-in-Place (SIP) systems.
3. Validation & Risk Management
oDevelop validation/verification master plans and qualification protocols.
oPerform risk assessments (e.g. FMEA) and define critical attributes/process parameters.
4. Project Management & Compliance
oDevelop and maintain project plans schedules and issue tracking.
oEnsure compliance with regulatory requirements industry standards and quality expectations.
#LI-MV1
$36.40 - $49.50 an hour
Average base salary range - not including benefits or cost of living adjustment.
CAI Benefits:
Comprehensive Health Insurance coverage
24 days of Paid Time Off
ESOP/401K - 15% Company Contribution (US Only)
Company paid Life Insurance
Company paid Long Term Disability
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 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).
Employment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
