Job Description
Job DescriptionSalary:
Position: Reliability Engineer II
The Reliability Engineer II is responsible for ensuring equipment reliability and optimal performance within a regulated manufacturing environment. This role focuses on maintaining equipment in optimal condition, analyzing performance trends, and conducting risk assessments (including FMEAs) to support operational excellence and compliance.
The position involves both technical reliability engineering and field project coordination, supporting the execution of capital and improvement projects while ensuring adherence to regulatory and safety standards (cGMP, cGLP, cGCP).
Key Responsibilities
- Maintain equipment in optimal operating condition and drive continuous reliability improvements.
- Analyze equipment performance trends and implement corrective and preventive actions.
- Perform Failure Mode and Effects Analysis (FMEA) and risk assessments for systems and equipment.
- Execute multiple well-defined projects and assignments, ensuring timely and accurate documentation of results.
- Support and participate in projects from initial concept through final close-out.
- Coordinate and oversee field execution of projects in compliance with company policies, SOPs, and regulatory requirements.
- Support the Site Project Manager in project planning phases including estimates, bidding, scheduling, safety metrics, and cash flow tracking.
- Ensure compliance with global regulatory standards (cGMP, cGLP, cGCP) and environmental, health, and safety (EHS) guidelines.
- Coordinate multi-disciplinary project activities to support site operations and business needs.
- Identify technical issues and collaborate with stakeholders to develop effective solutions.
- Participate in the development and review of design documents, drawings, and specifications.
- Coordinate with external Architecture & Engineering (A&E) firms on project deliverables.
- Assist in preparing project estimates, bid packages, and procurement documentation.
- Oversee contractor activities, ensuring work is performed according to specifications, schedules, and safety standards.
- Ensure contractors complete required orientation and training under site programs (e.g., PPCE or equivalent).
- Promote and enforce cGMP principles and a strong safety culture within the workplace.
Qualifications
Education:
- Associate Degree in Engineering or related technical field (required)
Experience:
- Minimum of 5 years of experience in a similar role (e.g., Project Foreman, Reliability, Maintenance, or Field Engineering)
- Required: Experience in regulated industries such as Pharmaceutical, Biotechnology, or Medical Devices
Technical Skills & Knowledge
- Strong understanding of cGMP regulations and regulated environments
- Experience with equipment reliability, maintenance strategies, and lifecycle management
- Knowledge of FMEA and risk management methodologies
- Ability to analyze data and identify performance trends
- Experience in project coordination and field execution
- Ability to read and interpret engineering drawings and specifications
- Strong problem-solving and analytical skills
- Effective communication and teamwork abilities
Equal Employment Opportunity (EEO) Statement
The Company is an Equal Opportunity Employer and is committed to providing a workplace free of discrimination and harassment. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran status, or any other category protected by applicable federal, Puerto Rico, or local laws.