Sr. Maintenance Engineer

Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

Overview of this Position:

The Sr. Maintenance Engineer assists the Grand River Aseptic Manufacturing Maintenance & Reliability (M&R) department by specializing in facility and utility optimization and providing subject matter expertise on mechanical systems. Runs projects and oversees construction activities. Demonstrates, builds, and enforces best practices for all M&R projects and functions. Works closely with maintenance staff as SMEs to help coordinate inspections and repairs, as well as the testing and calibration of all instrumentation, electrical, and mechanical systems. Is responsible for ensuring safe, reliable, compliant, and efficient operation of equipment and systems used across plant assets in sterile production facilities. Defines and leads robust maintenance strategies, systems, and workflows that enable timely response to equipment failures and ensure high-quality repairs. Leverages technical expertise to proactively identify and implement solutions to sustain scalable, high-volume production facilities, driving continuous improvement in asset performance, regulatory compliance, and operability. Oversees, identifies the pertinence of, and executes NCRs, CAPAs, and Change Controls. Plays a leading role in the asset on-boarding and management process. Creates, revises, and helps manage M&R-related SOPs, and Standard Work Instructions. Provide troubleshooting and strategic production support, as necessary. Aids Maintenance, Reliability Engineering, and Manufacturing Process Engineering Management in day-to-day facilities administration. Oversee and supervise contractor-led projects executed during line outages and facility shutdowns.

Non-Negotiable Requirements:

• Bachelor of Science degree in engineering, science, or technical discipline.
• 10+ years of prior experience in a facilities/mechanical engineering position.
• Must have proficient computer skills in Microsoft Word, Excel and Outlook.
• Drafting, CAD, AutoCAD, and blueprint reading experience/training.
• 5+ years of experience in FDA regulated environment.
• Knowledge and skill in mechanical engineering design.
• HVAC and piping design experience highly desired.
• Expertise in CMMS best practices, data mining, and data analytics.
• Ability to comprehend and execute equipment repairs on state-of-the-art technologies in compliance with current best practices.
• Training, experience, and certifications in the following disciplines: predictive technologies, equipment repair best practices, RCM/TPM, spare parts methodologies, tribology, condition-based monitoring, OEE, and MTTR.
• Deep understanding of ISO 55000.

Preferred Requirements

• Knowledge of Microsoft Project or other project management software.
• Knowledge of GMP standards and ability to follow CFR guidelines.

Responsibilities Include (but are not limited to):

• Provide technical support for HVAC and piping projects, including assessing current building conditions, and determining appropriate recommended measures and designing and managing projects to address.
• Responsible for building automation and management systems, along with most mechanical and qualified utilities systems such as Water for Injection (WFI) and pure steam.
• Manage projects, supervise construction activities, and prepare turnover documentation and as-built drawings.
• Consult on HVAC system and equipment design for a wide range of projects, and work with other engineers, project managers, and construction professionals as needed to create and/or modify design parameters.
• Lead or participate in selection and appraisal of subcontractors and vendors.
• Write and edit Operation and Maintenance procedures for equipment and engineering processes.
• Study equipment performance for facilities and utilities operation and adjust or devise enhancements to optimize.
• Oversee corrective and preventive maintenance work in consult with maintenance staff.
• Write user requirements specifications for systems and equipment.
• Guide and assist Maintenance Planners in the development of Work Packages.
• Initiate change controls for additions/changes/decommissioning of qualified systems.
• Communicate with vendors and suppliers to arrange future work and/or follow up to obtain reports and data for completed work.
• Serve as subject matter expert for multiple critical systems or pieces of equipment.
• Identify and lead projects which decrease MTTR and increase MTBPL.
• Make additions and corrections to spare parts program as required (Deep ISO 55000 and ISO 14224 knowledge).
• Ensure PM and PdM program is executed on time, as planned, and with a high degree of precision.
• Execute facility and equipment audits and record-taking policies.
• Aid in writing and marshaling through purchase orders, contracts, work orders, change controls, and other documentation.
• Provide leadership and technical expertise in support of the asset management plan implementation and associated practices, to ensure maximum equipment availability and reliability at minimum life cycle cost.
• Create, revise, and help manage M&R-related SOPs, and Standard Work Instructions.
• Oversee, identify the pertinence of, and execute NCRs, CAPAs, and Change Controls associated with and on behalf of the Maintenance and Reliability Department.
• Participate in and lead audit teams; serve as a subject matter expert during audits.
• Create and keep current facility site plans.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.