Specialist, Manufacturing Maintenance

Job Description

About This Role
As a Specialist in Manufacturing Maintenance, you will be focusing on the upkeep and optimal function of our equipment and utility systems. Your expertise will ensure that manufacturing processes run seamlessly in alignment with Quality, Safety, and cGMP standards, directly contributing to equipment uptime. You will be at the forefront of developing maintenance strategies that are critical to our operations. Your role encompasses training and guiding junior technicians, managing safety protocols, ensuring the reliability of equipment spare parts, and overseeing both outsourced vendors and contractors. Your responsibilities will also include the meticulous documentation and closure of quality processes within Trackwise, as well as managing work orders through the Computerized Maintenance Management System (CMMS). As a vital team member, your position supports the daily activities of Process Maintenance, offers direction, and contributes to the reliability engineering function. With a hand in capital projects, you serve as a Subject Matter Expert (SME) for maintenance and spare part requirements. In essence, your role is pivotal in maintaining the synergy between various departments and ensuring the continuous improvement of our maintenance operations within the site's ecosystem.

What You’ll Do:

• Develop and implement maintenance strategies for manufacturing process systems in compliance with Quality, Safety, and cGMP standards.
• Train and provide guidance to junior maintenance technicians.
• Oversee safety protocols and equipment spare parts reliability within the team.
• Manage relationships with outsourced vendors and contractors, including their onboarding and training.
• Support and document investigations and close quality processes within Trackwise.
• Review, approve, and close department work orders in the CMMS.
• Track and analyze department compliance metrics, ensuring work order management and adherence to safety and GMP processes.
• Provide daily support and direction to the Process Maintenance team.
• Assist with reliability engineering, especially concerning equipment spare parts and end-of-life management.
• Contribute as a SME to capital projects, defining and approving maintenance-related spare parts and maintainability.
• Recommend and implement CMMS system improvements for enhanced reliability and labor optimization.
• Assist with training, corrective and preventive actions (TRN, CAPA), and GCC compliance.
• Provide audit documentation support and maintain equipment in a compliant state within operational expense budgets.
• Engage with various site functions including Manufacturing, Lab, and others to offer support and maintenance expertise.

Who You Are:
You are the backbone of our manufacturing maintenance operations, bringing both leadership and technical acumen to our team. You thrive on mentoring others and setting safety as a priority in a high-stakes environment. Your ability to manage multiple vendor and contractor relationships speaks to your strong organizational skills and your focus on collaboration. You're proactive in identifying and implementing maintenance strategies that enhance our operational efficiency and compliance. You approach problem-solving with a blend of technical skill and creativity, ensuring that risk to operations and personnel is managed effectively. With your customer-oriented mindset and SME-level technical skills, you are always prepared to resolve technical issues and enhance our maintenance processes.

Qualifications

• High School and 7 yrs of relevant experience OR Associates Degree and 5 yrs of relevant experience.
• Strong background in equipment and utility maintenance within a manufacturing environment.
• Proven experience in developing and implementing maintenance strategies compliant with Quality, Safety, and cGMP standards.
• In-depth knowledge of CMMS and experience in managing work orders.
• Familiarity with quality process documentation and closure within systems like Trackwise.
• Experience in vendor and contractor management.
• Knowledge of reliability engineering and spare parts management.
• Proficiency in supporting capital projects as a maintenance SME.
• Ability to provide technical solutions and support for maintenance-related issues.
• Competency in contributing to the creation of new maintenance procedures and PMs.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make