Full-Time
Process Engineer
CAI
501-1,000 employees
Operational readiness consulting for pharma
No salary listed
Ireland
In Person
 Biology & Biotech (2) |
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- Bachelor’s degree in Chemical, Biotechnology, or Biochemical Engineering.
- 3–5+ years of hands-on experience in downstream bioprocess operations; upstream experience is a plus.
- Strong background in full lifecycle commissioning & qualification of biopharmaceutical equipment.
- Demonstrated experience with bioreactors and filtration systems, including protocol writing and execution.
- Experience supporting cGMP manufacturing operations in pharmaceutical or biotech facilities.
- Knowledge of PCS7 functional specifications; Siemens PCS7 experience preferred. Knowledge of DeltaV is a plus.
- Familiarity with design principles, sanitary design, and operation of biopharmaceutical manufacturing equipment.
- Strong written and verbal communication skills in English.
- Proficiency with MS Office.
- Willingness to travel up to 50%.
- Lead conceptual, basic, and detailed design for process equipment and utilities.
- Support full lifecycle Commissioning & Qualification (C&Q) of complex biopharmaceutical equipment, including bioreactors, filtration skids, tank farms, autoclaves, parts washers, and CIP systems.
- Author, review, and execute C&Q protocols (IQ/OQ/PQ).
- Participate actively in all project phases: design, commissioning, qualification, and handover.
- Collaborate with multi-disciplinary teams, including Process Engineering, Automation, Manufacturing, PDTS, and Validation, to implement improvements and changes.
- Ensure compliance with applicable EHS requirements, cGMP, and Good Engineering Practices (GEP).
- Coordinate and manage engineering and construction consultants, equipment vendors, and contractors.
- Provide process expertise in upstream and downstream bioprocess operations to support equipment design and project implementation.
- Senior-level C&Q engineer background with hands-on execution experience.
- Exposure to both upstream and downstream processes, especially bioreactors and filtration systems.
- Proven track record in GMP biotech/pharma projects.
CAI Technical Consulting Malaysia SDN (cagents.com) delivers operational readiness consulting for pharmaceutical, biotechnology, and healthcare clients to prepare for full-scale production. It works by conducting operational readiness assessments and then providing tailored implementation plans that cover project planning, production operations, asset management, reliability, and sustainability, plus specialized services like Digital Pathology Validation for Leica Biosystems. The firm differentiates itself through active industry collaboration, ongoing professional development, and a global, hands-on approach that pairs quick assessments with practical, cost-effective solutions. Its goal is to help clients achieve operational excellence and successful scale-up by delivering ready-to-deploy strategies and compliant processes.
Company Size
501-1,000
Company Stage
Pre-seed
Total Funding
$3.4M
Headquarters
Indianapolis, Indiana
Founded
1996
Simplify's Take
What believers are saying
- JLL Partners investment expands CAI globally across four continents for 700 professionals.
- Fedegari partnership integrates turnkey sterilization, cutting biotech lifecycle costs.
- CAI's CQV services marked 30 years in 2026, accelerating facility compliance worldwide.
What critics are saying
- Oracle Life Sciences automates CQV with cloud platforms, eroding CAI's share in 12 months.
- Fedegari sells sterilization systems directly, capturing pharma clients in 18 months.
- JLL-mandated expansion dilutes CAI expertise, causing CQV failures in 24 months.
What makes CAI unique
- CAI specializes in commissioning, qualification, and validation for life sciences facilities.
- CAI delivers operational readiness assessments for biotech and pharma full-scale production.
- CAI pioneered neurodiversity hiring in enterprise consulting services.
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Benefits
100% Employee Owned
24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
Professional Development (Approximately $5,000 paid career-related, continuing education)
ESOP/401k – 15% Company Contribution
Company Paid Long-Term Disability
Company Paid Life Insurance
Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
Other Benefits Depending on Country