Reliability Centered Maintenance (RCM) Specialist - Pharmaceutical Manufacturing
SRG · Center, IN · 1 mo ago
EngineeringContract
Location: Indianapolis, Indiana (transitioning to Lebanon, Indiana). Work Arrangement: Onsite (approximately 75% onsite); Long-term contract.
About the role
We are seeking a Reliability Centered Maintenance (RCM) Specialist to support a greenfield pharmaceutical manufacturing operation as it transitions from construction and installation through to operational hand-off. This role will play a key part in developing and implementing maintenance strategies that improve equipment reliability, maintainability, and regulatory compliance, working closely with Reliability Engineers and cross-functional teams in a fast-paced, large-scale build environment.
Qualifications
- Associate's degree in electrical or mechanical technology/engineering, industrial maintenance, or a related field, with 6+ years of relevant experience preferred; OR 12+ years of relevant experience in lieu of a degree
- Experience in reliability centered maintenance (RCM) or a similar role
- Working knowledge of Failure Mode and Effects Analysis (FMEA) and RCM methodologies
- Strong analytical and problem-solving skills
- In-depth knowledge of maintenance practices and equipment reliability within a cGMP pharmaceutical manufacturing environment
- Strong verbal and written communication skills for effective cross-team collaboration
- Familiarity with industry regulations and compliance standards
- Manages reliability and maintenance/writing FMEAs for parts and equipment that is not on site yet.
Responsibilities
- Maintenance Strategy Development
- Collaborate with planners/schedulers and Reliability Engineers to prioritize work according to project schedules
- Develop Failure Mode & Effects Analysis (FMEA) data to evaluate components, assemblies, and subsystems for potential failure modes, causes, and effects
- Support the development of maintenance strategies that enhance equipment reliability
- Create maintenance job plans tailored to the specific needs of individual assets
- Review vendor requirements and recommendations to inform a comprehensive reliability strategy
- Participate in the development of maintenance reliability procedures
- Risk Analysis and Compliance
- Assist with FMEA to identify potential failures and their operational impacts
- Ensure compliance with regulatory standards throughout all maintenance processes, including cGMP and CFR 21 requirements
- Collaboration and Communication
- Facilitate communication across departments to align maintenance activities with project goals
- Work closely with production, quality assurance, and engineering teams
- Report on task status and progress to Reliability Engineering and planning teams to support metrics tracking and project success