Operations Analyst 2

About the Role

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine, offering a differentiated portfolio of allograft and xenograft biomaterials at scale. This role involves validating equipment, understanding critical processes, and supporting manufacturing engineering initiatives across multiple locations.

Responsibilities

• Validate equipment, interfaces, and control systems for manufacturing processes.
• Provide manufacturing engineering support and recommendations for direct projects.
• Define and implement technical solutions, completing tasks and documenting results.
• Write and execute validation protocols and summary reports.
• Lead development and improvement of manufacturing processes for existing and new products.
• Develop inspection plans for new and existing materials.
• Facilitate quality remediation through partnerships with quality engineers.
• Support or lead non-conformance investigations, CAPAs, and corrective actions.
• Support or lead capital equipment projects for new manufacturing lines and upgrades.
• Collaborate cross-functionally on lean manufacturing, cost savings, capacity, and new product launches.
• Produce documentation for standard operating procedures within the company’s quality system.
• Lead continuous improvement efforts using time studies, value stream analysis, and lean methodologies.
• Recommend and implement changes to achieve team goals in quality, cost, delivery, and safety.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in an engineering discipline.
• 4-6 years of engineering experience in designing, modifying, and implementing processes and equipment.

Skills

• Proficiency in Microsoft Office Suite, including advanced Excel.
• Experience with Computer Aided Drafting (CAD) software.
• Excellent verbal and written communication skills.
• Project management expertise.
• Strong problem-solving methodologies.
• Technical writing and statistical analysis skills.

Safety & Physical Requirements

• Ability to move or lift objects up to 25 pounds.
• Frequent (>75%) stationary position (standing or sitting) while using digital displays.
• Frequent (>75%) fine manipulation using hands and fingers (typing, writing, etc.).

Working Environment

• Onsite: Office environment with assigned workstation.

Benefits

• Paid Time Off (PTO).
• 401(k) with up to a 6% company match.
• Holiday pay.
• Medical, dental, and vision insurance.
• Short-term and long-term disability coverage.
• Paid parental leave.
• Annual bonus opportunity up to $6,000.

About Evergen

Evergen provides end-to-end services, including design, development, regulatory support, verification, validation, manufacturing, and supply chain management. The company is committed to quality, integrity, and patient safety, guided by five core values:

• Accountable: Own actions and decisions.
• Agile: Embrace change to drive innovation and growth.
• Growth Mindset: View challenges as opportunities for learning.
• Customer-Centric: Prioritize customers at every touchpoint.
• Inclusive: Celebrate diversity and ensure every voice is heard and respected.

Evergen is Great Place to Work® Certified and fosters an inclusive workplace. Montagu Private Equity supports Evergen’s growth and transformation as the CDMO of choice in regenerative medicine.