SR Specialist, Maintenance & Engineering Compliance
Description
The incumbent will be responsible for the oversight of Engineering, Maintenance and Calibration technical compliance through equipment lifecycle traceability, deviation reporting, CAPA’s, change controls, contractor work overview and development/revision of procedures and forms. The incumbent is responsible for management of master maintenance data upkeep, report generation, Maintenance & Engineering LOS oversight and the Maintenance & Engineering site library for projects and equipment. Incumbent will also be responsible for assisting with audits and report generation within BIAH and vendors used by Maintenance and Engineering. The incumbent will assist in instituting the oversight of best-practice procedures for compliance and risk mitigation.
Duties & Responsibilities
• Manage MDM data integration and updates in support of CMMS to ensure equipment and cost traceability, and work stream compliance reporting and update requirements in a compliant and detailed manner.
• Perform change controls and CAPAs as well as oversight in support of Maintenance & Engineering compliance for projects and equipment changes.
• Strict oversight of completed Contractor work orders and paperwork processing to ensure that all entries are complete and paperwork is filed and stored in a compliant manner.
• Manage Maintenance & Engineering Compliance Library. Ensure equipment, project information, performance qualifications and other Validation or Engineering documentation is categorized filed and controlled in an Inspection ready state.
• Prepare SOP’s and forms for workflows within BIAH document systems and update items as necessary for Maintenance & Engineering.
• Integrate a process and cultures of compliance, through maintaining GxP with documentation, training, processes, understanding regulation guides and corporate requirements for validated systems.
• Assist with queries in CMMS to develop and run mandated KPI’s and reporting as necessary to support BI corporate / departmental requirements and to support E&T maintenance North American OPU goals and activities
Requirements
• Bachelor’s degree and a minimum 4 years of GxP life sciences/pharma experience or Associate degree and a minimum of 6 year of GxP life science/pharma experience or High School Diploma(or GED) and a minimum of 8 years of GxP life sciences/pharma experience required.
• Work Experience: Minimum of 3 years experience as a SAP key user or +5 years related SAP experience.
• Experience executing deviations, investigation, CAPAs, change control, etc. preferred.
• Working knowledge of cGMP, EU and USDA guidelines as they pertain to fulfilling the CMMS & Master Data Management, equipment traceability and documentation handling and storage.
• Demonstrates the willingness to learn, develop and comply with any/all departmental SOP’s.
• Exceptional attention to detail and highly organized to fit high through put workplace
• Good communication and writing skills required
• Computer Skills: Must be proficient in MS Office software, including Visio, Excel, Word, and Power Point.
• Must have ability to develop training materials and perform training and communication to all levels of the Company.
• Experience and
Eligibility Requirements
• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older
Pharmaceutical Manufacturing
Management and Manufacturing
Full-time