Maintenance Coordinator Jobs

Job Title:Engineering & Maintenance Coordinator/ Support Specialist

Job Type:Direct Hire (Salaried FTE) role for our client

Reporting to:Engineering & Maintenance Manager

We are seeking a detail-oriented and experienced Maintenance Coordinator and Support Specialist to join our client's growing team. The ideal candidate will have a strong understanding of the principles of engineering and maintenance, as well as hands-on experience in a cGMP regulated environment. The successful candidate will be responsible for coordinating maintenance activities, ensuring that all equipment and facilities are properly maintained and in compliance with regulatory requirements while maximizing operational efficiency. Key requirements for this position include experience with Computerized Maintenance Management Systems (CMMS), Corrective and Preventive Actions (CAPA), Validation, Deviations, Quality Assurance (QA), and Change Control.

Key Responsibilities

·Coordinate and support the planning, scheduling, and execution of preventive and corrective maintenance activities for equipment and facilities, ensuring compliance with cGMP and regulatory requirements.

·Utilize CMMS to manage work orders, track equipment history, and analyze maintenance data to improve equipment performance and reliability.

·Participate in the investigation and resolution of deviations, ensuring timely and accurate documentation and implementation of corrective and preventive actions (CAPA).

·Collaborate with cross-functional teams, including QA, Engineering, and Production, to develop and implement validation protocols, ensuring the qualification and validation of equipment, processes, and systems.

·Assist in managing and executing change control processes, ensuring proper documentation, review, and approval of changes to equipment, processes, and systems.

·Support the development, implementation, and continuous improvement of standard operating procedures (SOPs), work instructions, and maintenance best practices.

·Coordinate with QA to ensure timely resolution of audit findings and implementation of corrective actions related to maintenance activities.

·Participate in ongoing training and development to maintain current knowledge of cGMP regulations, industry best practices, and emerging technologies.

·Writing, editing, reviewing, updating the departmental technical documents such as the Standard Operating Procedures (SOP’s), Protocols and summarizing technical information, Change controls.

·Work to close approved CAPA’s through completion of the listed action steps.

oWill directly implement documents changes and updates.

oAssists in identifying the mitigations for internal audit observations, where applicable.

·Ensures timeliness of calibrations and performance maintenance on GMP equipment.

·Ensures that all files of GMP equipment are up to date and accurate.

·Management of CMMS (Administrator).

·Adheres with all compliance programs and company policies and procedures.

·Any other duties as assigned.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Qualifications

·Solid understanding of cGMP regulations, FDA guidelines, and other relevant industry standards.

·Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.

·Exceptional problem-solving and analytical abilities.

·Proficiency in using CMMS and other maintenance-related software.

·Advanced knowledge of the operational principles of pharmaceutical manufacturing equipment and processes as they pertain to liquid filling.

·Adaptability and willingness to learn and stay current with industry trends and best practices.

·Excellent document and report writing using scientific language

·Excellent at reviewing documentation written by other writers to ensure clarity, completeness, accuracy, and overall quality standards

·Expert skills in Microsoft Suite.

·Strong written and oral communication skills in English.

·Minimum 3-5 years of experience in maintenance and support roles within a cGMP pharmaceutical production facility.

·Strong knowledge and experience with CAPA, Validation, Deviations, QA, and Change Control.

Preferred Qualifications

·Bachelor’s degree specializing in Engineering or Science in related discipline - relevant experience may be considered in lieu of a degree.

·Experience working within company-wide information systems