GMP Facilities/Plant Engineer - Morrisville, United States - Kriya Therapeutics

Description

Position Summary
The GMP Facilities/Plant Engineer will be the responsible engineer for the facility's GMP utilities and cleanrooms. This individual will be responsible for ensuring these systems are operating reliably and properly maintained, performing troubleshooting as needed.

Additional responsibilities include overseeing the facility's alarm response, deviation, change control, and CAPA management, ensuring compliance with Good Manufacturing Practices in a biotech manufacturing environment.

This individual will also play a crucial role in managing the Computerized Maintenance Management System (CMMS) and participation in project teams by serving as the representative of the facilities group.

Primary Responsibilities

• Serve as the responsible engineer for GMP facilities and utilities such as HVAC systems, clean gases, boilers, chillers, waste systems, and cleanrooms.
• Respond promptly to all facility alarms, identifying and rectifying issues that may impact operations or compliance.
• Develop strategies to minimize alarm occurrences and enhance the facility's overall reliability.
• Lead facility related deviation, change control, and Corrective and Preventive Action (CAPA) processes in compliance with company procedures and GMP regulations.
• Act as a facilities representative in internal investigations and audits, working closely with quality and compliance teams to address issues and implement corrective actions.
• Oversee the facility portion of the Computerized Maintenance Management System (CMMS), ensuring accurate data input, system functionality, and maintenance of equipment records.
• Work collaboratively with cross-functional teams to ensure efficient resolution of facility concerns.
• Conduct regular assessments of utility systems to analyze capacity, efficiency, and reliability, identifying opportunities for optimization and improvement.
• Establish and monitor KPIs for facility operations, focusing on efficiency, compliance, and reliability.
• Identify trends, areas for improvement, and opportunities for enhanced performance.
• Collaborate with multidisciplinary teams on special projects related to facilities, providing technical expertise and guidance as needed.
• Contribute to the design, implementation, and completion of various facility-related projects.

What You Bring to the Team
Education & Experience

• Bachelor's degree in Engineering or related field. Mechanical engineering background preferred.
• 0-3 years of experience in a GMP-regulated environment within the biotech, gene therapy or related industry.

Competencies

• Knowledge of GMP regulations and their application in a manufacturing setting.
• Experience with plant/utility systems
• Experience in managing a Computerized Maintenance Management System (CMMS)
• Strong problem-solving skills with a keen eye for detail.
• Ability to work independently and collaboratively in a team environment.
• Excellent communication and interpersonal skills.

Working Conditions and Physical Demands

• Work is normally performed: at a desk
• Lifting requirements: Under 20 lbs
• Travel requirements: None
• Must be able to drive between two local facilities.
• May need to respond to after-hours facility needs

About Kriya

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

What We Offer
Medical, Dental and Vision with 100% employee premium coverage ? Retirement matching ? Short and long-term disability benefits ? 12 company paid holidays ? Generous Time Off ? Cyber Safety protection ? EAP ? Company paid life insurance ? Equity ? and more
Kriya is an equal opportunity employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.

All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently.

Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.

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