Posted: 06/05/2025 Job Number: 40821

Job Description

Engineer

Top 3 Must Have Skill Sets:

Experience working in commercial biotech manufacturing industry.
Strong drive and proven results in solving complex and ambiguous problems.
Demonstrated ability to work well in highly collaborative environments.

Red Flags:

Gaps in employment without clear justification
Not a maintenance role: They design/own the equipment and support proper maintenance planning, not execution.
Not a research role. Candidates with advanced degrees seeking research roles should not be submitted.
Lack of biotech experience.
Lack of desired degree (Chemical, Mechanical, or Biomedical Engineering).
Rigid personalities or candidates uncomfortable with ambiguity or startup-like agility

Summary:

This opportunity is based at a brand-new, advanced biologics manufacturing plant. The site features a cutting-edge FleX Batch facility that combines the latest in disposable technologies with traditional stainless-steel systems, enabling maximum operational flexibility. The facility integrates best-in-class manufacturing processes and industry 4.0 capabilities, along with sustainability initiatives designed to reduce carbon emissions and waste.

What you will do

In this role, the Engineer will report to the Senior Manager of the Process Engineering group and will provide daily engineering support to the site.

Responsibilities:

Serve as system owner for process equipment and systems supporting manufacturing operations.
Provide engineering support for design, construction, startup, commissioning, and qualification of new or modified systems.
Identify and/or lead implementation of small-to-medium scale equipment or facility improvements, including development of business cases.
Develop maintenance programs, ensure spare part availability, and coordinate execution to maintain system reliability.
Ensure systems operate safely and in compliance with EHS standards and regulations.
Support commissioning and qualification activities in alignment with GMP requirements and regulatory inspections.
Apply engineering principles in daily operations, maintenance, and troubleshooting of plant systems.
Monitor system performance and implement risk-reduction strategies.
Lead or support troubleshooting efforts to minimize production downtime, including root cause analysis and CAPA implementation.
Support new product and technology introductions via engineering assessments, equipment modifications, and pilot runs.
Advance use of predictive maintenance and condition-based monitoring using data analytics where applicable.
Lead or contribute to deviation investigations and other quality-related processes.
Analyze and present findings related to operational issues and engineering projects.
Provide technical support to commercial and clinical manufacturing, specifically in process control and equipment.
Collaborate with cross-functional groups such as manufacturing, process development, utilities, maintenance, quality, and validation to drive operational improvements.
Maintain regular communication with leadership and team members, escalating issues with proposed solutions.
Participate in a small engineering team on a project or ongoing support basis.
Provide rotational on-call support for utility systems, including nights, weekends, and holidays as needed.
Participate in the design and selection of systems, instrumentation, and components.
Evaluate supplier capabilities and assess new technologies to improve cost, throughput, or technical capabilities.

What we expect of you

We value diverse perspectives and contributions. The engineering professional we seek is dynamic, adaptable, and team-oriented, with the following qualifications:

Basic Qualifications:

Master degree

Bachelor degree and 2 years of experience

Associate degree and 6 years of experience

High school diploma / GED and 8 years of experience

Preferred Qualifications:

Bachelor’s degree in Chemical or Mechanical Engineering.
6+ years of relevant work experience, including 5+ years in a biopharmaceutical manufacturing environment.
Hands-on experience with GMP production equipment such as bioreactors, centrifuges, filtration systems, and purification technologies.
Proficiency with equipment and facility control systems, including troubleshooting and logic understanding.
Experience in regulated environments (e.g., cGMP, OSHA, EPA) and knowledge of quality systems (e.g., change control, non-conformances, CAPA, validation).
Strong communication, technical writing, and presentation skills; ability to work independently.
Proven team collaboration and facilitation skills.
Analytical thinking with the ability to interpret complex problems using multiple data sources.
Ability to support capital projects and implement process improvements.
Understanding of capital project execution from procurement through validation in GMP environments.
Commitment to safety and compliance in all engineering activities.
Self-starter with excellent organization, time management, and multitasking skills.
Willingness to work flexible hours in support of 24/7 manufacturing operations.

Pay range is $29 - $34 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.

For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.

Meet Your Recruiter

Krista McIlwaine

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