Job Description

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Senior Process Technician is a critical role within the Engineering and Facilities team at Abzena. It requires hands-on problem solving and upkeep of complex equipment, instrumentation and process systems in a fast-paced, innovative cGMP environment. The Senior Process Technician executes planned and unplanned maintenance and repairs to ensure the timely and efficient production of GMP products. This role must collaborate with the Manufacturing, Development and Analytical teams to ensure timely completion of maintenance events, documentation of events utilizing a Computerized Maintenance Management System (CMMS) and maintenance of an accurate spare parts inventory. As an SME, the Senior Process Technician will understand and be able to support and train other technicians as well as Manufacturing and Development staff on the setup, operation, and function of systems of cGMP and development equipment. They will work to identify areas of continuous improvement in the set-up and maintenance of cGMP and development equipment and provide operational support for validation and other projects.

Responsibilities

• Ensuring all applicable manufacturing and development equipment has a compliant preventative maintenance program assigned to ensure reliability of equipment and control systems in the plant.

• Overseeing and performing planned and unplanned maintenance activities of production and development equipment.

• Manage and utilize the Computerized Maintenance Management System (CMMS) for accurate and compliant asset data management.

• Manage work order documentation from initiation to closure, ensuring compliance with Good Documentation Practices.

• Support the execution of validation activities, ensuring compliance with industry standards.

• Oversee and manage small to medium-scale projects, focusing on cGMP manufacturing improvements and efficiency enhancements.

• Assist in the development and revision of standard operating procedures to provide information to complete tasks in a standardized and consistent manner.

• Conduct spare parts assessments and manage inventory to support ongoing operations.

• Prioritize and plan safety-related work orders, maintaining a safe working environment.

• Develop, track and action metrics for planned and unplanned maintenance, driving continuous improvement.

• Support deviations, perform investigations and develop CAPAs to address and prevent recurrence of excursions, anomalies or failures.

• Support both internal and external audits. Address audit actions with a timely action driving resolution and compliance.

Qualifications

• H.S. Diploma or General Education Degree (GED)

• >5 years of experience as a maintenance technician in an industrial, pharma/biotech, or manufacturing environment

• Experience in troubleshooting and repair of manufacturing and development equipment such as chromatography and TFF systems, temperature control systems, mix/hold tanks, reactors, isolators, lyophilizers, etc.

• Experience with automation systems and platforms

• Demonstrated ability to assess and improve maintenance and asset management processes.

• Ability to work well independently with minimal supervision as well as in a heavily team-focused environment

• Customer focused, with ability to multi-task and maintain a high quality of work

• Strong organization and problem-solving skills

• Strong documentation skills, adhering to Good Documentation Practices.

• Excellent communication and interpersonal skills, facilitating effective cross-functional collaboration.

• Familiarity with FDA, EudraLex, and ISO regulations related to GMP manufacturing.

• Proficiency in MS Office Suite and experience with equipment/asset management databases.

• Proficient written and verbal communication skills with the ability to communicate effectively across all levels and functions of business

• Associate’s degree in life science, mechanical, or technical studies in a related field

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training