Equipment Reliability Engineer

2 weeks ago

Warren, United States Axelon Services Corporation Full time
Job Overview:

Position Purpose:

The Equipment Engineer plays a crucial role in ensuring the efficient functioning of laboratory and clinical manufacturing processes through collaboration with internal teams and external service providers.

The individual is expected to perform tasks assigned by management with a high degree of independence.

The Equipment Engineer is accountable for managing deviations, CAPAs, and change controls, as well as drafting calibration and maintenance Standard Operating Procedures (SOPs). This role also involves executing calibrations, maintenance, and qualifications/validations.


Essential Qualifications:
Proficient understanding of cGMP, GXP, GAMP, and SDLC regulations, including 21CFR part 11, along with computer systems validation requirements and best documentation practices.
Familiarity with pharmaceutical, manufacturing, and laboratory systems and equipment.
Expertise in calibration management and environmental monitoring systems.
Strong analytical skills and the capability to work autonomously.

Excellent communication and interpersonal skills, with experience engaging a diverse workforce where individual initiative and accountability are essential.

Demonstrated ability to manage multiple tasks effectively.

Proficient in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook; a natural aptitude for learning new software, including corporate intranet and enterprise applications.

Basic knowledge of scheduling and inventory management systems is preferred.
Ability to collaborate effectively with Quality Control, Manufacturing, Quality Assurance, and Facilities teams.

Key Responsibilities:
Operational Duties:
Conduct equipment calibration, preventive maintenance, performance verification, and repair tasks in laboratory and manufacturing settings.
Oversee vendor activities related to calibration, preventive maintenance, performance verification, and repair functions.
Review and validate vendor-executed calibration, maintenance, repair, and performance verification documentation for accuracy and completeness.
Ensure proper filing of all calibration, PM, and performance verification records post-approval.
Execute requalification on Controlled Temperature Units (e.g., Refrigerators, Freezers, Incubators, Cryotanks, and Cryopods).
Support multiple sites as required.

Manage and support deviations and investigations stemming from calibration or performance verification activities, while developing and implementing corrective and preventive actions.

Draft and assist in the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment.

Facilitate the development, review, and approval of calibration and maintenance plans within the site CMMS system.
Assist in executing process improvement studies as necessary.

Adhere to established policies and procedures governing Laboratory Systems Management activities and the equipment managed to ensure compliance with approved standards.

Maintain positive relationships with site customers and external vendors while fostering a collaborative team environment.

Comply with cGMP practices and ALCOA principles, ensuring that data is Attributable, Legible, Contemporaneous, Original, and Accurate, along with additional guidance for data completeness and consistency.

Inventory Management:
Collaborate with the Planning group to ensure system updates as calibration, maintenance, and performance verification activities are completed.
Approve Change Requests, Asset Inductions, and Work Requests.
Validate Calibration and Maintenance documentation.
Conduct investigations as needed.
Review and endorse calibration and maintenance work.
Regulatory Compliance:
Maintain all required Corporate, Facilities, and EHS training as mandated.
Adhere to all safety protocols and hazard communication standards.
May serve as a Subject Matter Expert during internal and regulatory audits.

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