About the role

Aplyr's Quick Take

This role is for a Process Engineer focused on the commissioning and qualification of biopharmaceutical equipment. You'll be involved in the design and lifecycle management of systems like bioreactors and filtration units, working closely with various engineering and manufacturing teams. It's primarily an individual contributor role with some project leadership responsibilities.

Good fit

Ideal candidates have a Bachelor's in Chemical or Biochemical Engineering and 3-5 years of relevant experience in biopharmaceutical processes. A collaborative working style and strong technical expertise in downstream operations are essential.

Worth noting

The position emphasizes employee ownership and a commitment to integrity and service, which may appeal to those looking for a supportive company culture. However, the role may involve significant project management responsibilities, which could be a red flag for those preferring strictly technical positions.

Process / Commissioning & Qualification (C&Q) Engineer – Biopharmaceuticals

About CAI

CAI is a dynamic, 100% employee-owned company founded in 1996, now encompassing over 800 employees globally. We specialize in Commissioning, Qualification, Validation, start-up, project management, and consulting services across FDA-regulated and other mission-critical industries. Our offices span the United States, Singapore, Australia, Ireland, and across North & South Europe. Learn more at www.commissioningagents.com.

Our Commitment to Excellence:

At CAI, we prioritize our clients’ success and persist until excellence is achieved. As employee-owners, we uphold our Foundational Principles:

Integrity: We act with the utmost integrity.

Service: We serve one another, our clients, and society.

Sustainability: We work for our future.

We believe that individual success drives collective success. Teamwork, respect, and a positive can-do attitude fuel our growth and client satisfaction.

Position Overview:

We are seeking Senior Process / C&Q Engineers to join our expanding operations, supporting an exciting biopharmaceutical project focused on both upstream and downstream operations. This role involves working with bioreactors (10L to tens of thousands of litres), filtration systems, and other complex equipment, supporting full lifecycle Commissioning & Qualification (C&Q) for GMP drug manufacturing.

Responsibilities:

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.

Required Qualifications:

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%.

Preferred Experience:

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.

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Skills & Tags

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Aplyr's read

CAI leverages cutting-edge AI and automation to streamline business processes, attracting skilled engineers and project managers in validation and commissioning roles.
Synthesized from recent postings & public sources

What's promising

•CAI focuses on AI-driven solutions, offering cutting-edge technology to enhance business efficiency.
•The company has a strong emphasis on hiring experienced engineers, indicating a commitment to technical excellence.
•CAI's involvement in data center projects highlights its role in critical infrastructure development.

What to watch

•Limited public information about CAI's financial stability and growth prospects.
•High concentration of roles in validation may limit opportunities for diverse career paths.
•Potential challenges in maintaining innovation pace in a rapidly evolving AI industry.

Why CAI

•CAI specializes in automation and AI, setting it apart in business process enhancement.
•The company is deeply involved in mission-critical data center projects, emphasizing its technical expertise.
•CAI's focus on validation and commissioning roles highlights its niche in quality assurance and project execution.

Aplyr’s read is generated by AI from public sources. Was it useful?

About CAI

CAI

cagents.com

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CAI is a company that specializes in providing advanced technology solutions, focusing on automation and artificial intelligence to enhance business processes.