Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-POKN-C Cherokee STL Engineering
Recruiter: Michelle Matthews
This information is for internals only. Please do not share outside of the organization.
Your Role:
Reporting to the Head of Engineering, the Engineering and Maintenance Compliance Specialist's primary role is to provide support to the cGMP operations. This position will be responsible for assisting Engineering, Manufacturing, and Validation with quality support as it relates to SAP CMMS admin., change control, equipment non-conformances, equipment deviations, routine maintenance plan updates, and Building Management System alarm response and support. Additional responsibilities may include on the floor oversight during maintenance shutdowns, incident investigations and resolution, monitoring of the building management system. Job Responsibilities include:
- Coordinate documentation and tasks associated with equipment and facilities.
- Change management.
- Addition of new equipment to SAP
- Addition of Preventative maintenance and Calibration plans.
- Technical document writing of reports, quality records, and maintenance plans.
- Alarm response tracking.
- Work with Engineering, Technical Operations, Maintenance, Manufacturing, Validation, and Quality Assurance to ensure that change controls, deviations, CAPAs are reviewed, approved and implemented as appropriate
- Assist with equipment and facility investigations, troubleshooting, and root cause analysis
- Assist with the management of preventative maintenance tasks, change control, and equipment/facility shut-down activities.
- Perform updates to CMMS in compliance with cGMP.
- Generate, review and close work orders as needed in CMMS.
- Assist with equipment and facility risk assessments and mitigation
- Ensure planned and unplanned work is prioritized and managed closely to minimize disruptions to Operations' schedule.
- Maintenance of quality systems and cGMP compliance for Engineering, Maintenance, and Validation.
- Ability to understand regulatory requirements such as ICH Q7
- Support equipment commissioning, qualification, and validation activities related to GMP manufacturing.
- Create new assets and spare parts in CMMS
- Write, review and/or assist in the development of Facility and Equipment Operating Procedures
- Assist with internal, customer, and regulatory audits
- Write Engineering and Maintenance CAPA, deviation, and change control
- Write Quarterly alarm trending reports.
- Drive continuous improvement to Engineering and maintenance practices to support customer and regulatory expectations.
Who You Are
Minimum Qualifications:
- Associate Degree in a Chemistry, Controls Engineering, or other STEM discipline.
OR
- Vocational degree or certification in industrial maintenance, electronics, or other trade.
- 1+ years of experience in a GMP manufacturing or industrial role.
OR
- High School Diploma or GED
- 1+ years of experience in equipment systems administration
Preferred Qualifications:
- Associate Degree in Controls or Mechanical Engineering.
- 2+ years of experience in equipment systems administration
- Experience with TrackWise, Mango, and SAP or other QMS and CMMS systems, specifically for Quality Management and Engineering.
- Ability to work within a cross-functional team.
- Effective oral and written communication skills.
- Demonstrated use of Good Documentation Practices.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.