The Engineering QMS Manager is responsible for supporting Engineering Quality Management System (QMS) activities within a 503B sterile injectable manufacturing facility. The position supports the Engineering department in preparation, coordination, tracking, and maintenance of controlled documentation associated with deviations, CAPAs, change controls, preventive maintenance, calibration, equipment breakdowns, qualification activities, SOPs, engineering investigations, and other GMP-related Engineering records.
The individual will work closely with Engineering, Quality Assurance (QA), Production, QC/Microbiology, Validation, Warehouse, and other applicable departments to ensure Engineering QMS activities are completed accurately and within established timelines. This is a middle management position working under the guidance and technical oversight of experienced Engineering personnel.
Key Responsibilities
Engineering QMS Support
Support initiation, documentation, tracking, and closure of Engineering-related deviations, CAPAs, change controls, action items, and other QMS records.
Assist Engineering personnel in collecting information required for deviation and investigation documentation.
Maintain Engineering QMS trackers and follow up on approaching due dates.
Coordinate with Engineering personnel to obtain supporting evidence required for QMS closure.
Support preparation of Engineering responses to QA comments and document review observations.
Assist with effectiveness-check documentation and CAPA follow-up, as applicable.
Escalate overdue or potentially overdue Engineering QMS activities to Engineering management.
Deviation and Investigation Support
Assist with collection and organization of information for Engineering investigations, including equipment history, alarm records, maintenance records, calibration history, logbooks, drawings, photographs, vendor reports, and other supporting documentation.
Support preparation of investigation timelines and event chronologies.
Assist Engineering SMEs with documentation of root-cause analysis using approved investigation tools such as 5-Why analysis.
Support preparation of Engineering impact assessments under the direction of Engineering SMEs.
Track investigation actions through completion.
Ensure investigation attachments and supporting evidence are properly identified and maintained.
Responsibility Boundary
Final technical conclusions, root-cause determination, product-quality impact decisions, and QMS approvals remain the responsibility of qualified Engineering SMEs, Engineering management, QA, and other authorized personnel, as applicable.
Change Control
Support initiation and tracking of Engineering change controls associated with equipment, utilities, facilities, computerized/automation systems, and maintenance activities.
Coordinate collection of supporting documents such as drawings, specifications, quotations, risk assessments, qualification documents, vendor documentation, and implementation evidence.
Maintain implementation-action trackers and follow up with assigned action owners.
Assist in compiling Engineering evidence required for change-control closure.
Preventive Maintenance and Calibration
Coordinate with the Operations and Maintenance (O&M) team at site to ensure timely execution of calibration activities, preventive maintenance (PM), facility maintenance, and maintenance of associated logbooks.
Monitor compliance with scheduled maintenance and calibration activities and maintain effective communication with the O&M team regarding completion status.
Escalate any deviations, delays, or instances where the O&M team is unable to complete assigned activities within the established timelines, in accordance with the defined escalation matrix.
Maintain and periodically review Engineering preventive maintenance and calibration schedules.
Track upcoming PM and calibration due dates and notify responsible personnel of activities approaching approved due dates/windows.
Support reconciliation of completed PM/calibration records against the approved schedule.
Assist in maintaining equipment and instrument master lists.
Verify availability of completed work orders, calibration certificates, service reports, and associated documentation.
Escalate missing, incomplete, or overdue PM/calibration activities to Engineering management.
Support documentation associated with out-of-tolerance or overdue calibration events under SME supervision.
SOPs, Forms and Controlled Documents
Assist with preparation and revision of Engineering SOPs, preventive maintenance checklists, logbooks, forms, equipment records, and work instructions.
Coordinate Engineering document reviews and incorporation of review comments.
Support periodic review of Engineering SOPs and associated controlled forms.
Ensure current approved Engineering documents are being used.
Support archival and organization of superseded Engineering records in accordance with site procedures.
Equipment and Utility Documentation
Support GMP documentation associated with pharmaceutical equipment and critical utilities, including, as applicable:
Purified Water (PW) and Water for Injection (WFI) systems
Clean/Pure Steam systems
HVAC and classified cleanrooms
Compressed air and nitrogen systems
Autoclaves and sterilization equipment
Filling and packaging equipment
Isolators and RABS
Environmental chambers and Biological Safety Cabinets
Process and laboratory support equipment
The position is primarily responsible for QMS/documentation support and is not expected to independently troubleshoot or make engineering design decisions.
Equipment Breakdown and Maintenance Documentation
Support documentation of equipment breakdowns and unplanned maintenance activities.
Collect service reports, photographs, replaced-part information, alarm information, and maintenance records.
Assist with preliminary Engineering documentation following equipment breakdowns.
Support assessment of whether additional QMS documentation is required by escalating events to responsible Engineering personnel.
Ensure completed maintenance documentation is properly filed and traceable to the applicable equipment.
Qualification and Validation Support
Assist Engineering/Validation personnel with documentation associated with equipment and utility qualification activities.
Support compilation and organization of DQ/IQ/OQ/PQ documentation.
Maintain qualification-document trackers.
Coordinate collection of vendor manuals, drawings, certificates, material certificates, calibration records, and technical documents.
Assist with resolution and tracking of qualification punch-list items and discrepancies.
Ensure supporting Engineering documentation is available before qualification packages are routed for approval.
Inspection and Audit Readiness
Maintain Engineering documentation in an inspection-ready condition.
Assist in retrieving Engineering records during FDA inspections, internal audits, customer audits, and regulatory assessments.
Support Engineering responses to audit observations under Engineering management guidance.
Assist with tracking Engineering commitments arising from audits and inspections.
Ensure supporting documentation can be readily retrieved and is appropriately organized.
GMP and Data Integrity Responsibilities
Follow applicable cGMP requirements, site SOPs, and approved procedures.
Follow Good Documentation Practices (GDP).
Ensure entries are complete, accurate, legible, attributable, and contemporaneous.
Follow applicable data-integrity requirements and ALCOA+ principles.
Never backdate, recreate, alter, or correct GMP records outside approved documentation practices.
Immediately escalate identified documentation discrepancies, missing records, overdue activities, or potential GMP compliance concerns.
Qualifications
Required
Bachelor's degree or diploma in Mechanical Engineering, Electrical Engineering, Instrumentation, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or another relevant technical/scientific discipline.
0-8 years of experience in pharmaceutical, biotechnology, medical-device, healthcare manufacturing, or another regulated manufacturing environment.
Basic understanding of cGMP principles and pharmaceutical Quality Management Systems.
Good technical writing, documentation, organizational, and follow-up skills.
Ability to prepare clear and concise technical records and manage multiple QMS actions and deadlines.
Working knowledge of Microsoft Word, Excel, PowerPoint, and Outlook.
Ability to read basic equipment manuals, technical specifications, and engineering drawings.
Good written and verbal communication skills.
Ability to work collaboratively with Engineering, QA, Production, QC, Validation, and other departments.
Preferred
Bachelor's degree in an Engineering discipline.
Fresh graduates with strong technical documentation and organizational skills may be considered.
Previous exposure to GMP documentation, maintenance, calibration, validation, or pharmaceutical utilities is preferred but not mandatory.
Preferred Knowledge
21 CFR Parts 210 and 211
FDA expectations applicable to 503B outsourcing facilities
USP requirements applicable to pharmaceutical water and sterile manufacturing
FDA aseptic-processing expectations
Preventive maintenance and calibration management
Deviations, CAPA, change control, root-cause investigation, and risk assessment
Equipment qualification and validation
Good Documentation Practices and data integrity / ALCOA+
Sterile manufacturing and contamination-control concepts
Key Competencies
Engineering Quality Management Systems (QMS)
GMP Documentation & Data Integrity
CAPA, Deviations & Change Control
Investigation Support & Root Cause Documentation
Preventive Maintenance & Calibration Tracking
Technical Documentation Management
Audit & Inspection Readiness
Equipment & Utility Documentation
Qualification & Validation Documentation
Regulatory Compliance
Organization & Attention to Detail
Cross-Functional Collaboration
Technical Writing & Record Management
Time Management & Follow-up
Continuous Improvement Mindset
What Success Looks Like
Timely completion and follow-up of Engineering QMS activities.
Effective control of overdue Engineering QMS actions.
High PM and calibration schedule compliance.
Accuracy and completeness of Engineering documentation.
Timely escalation of approaching QMS/PM/calibration deadlines.
Effective Engineering document and record retrieval.
High quality of initial QMS drafts and supporting documentation.
Audit and inspection readiness of Engineering records.
Full compliance with GDP and data-integrity requirements.
Engineering activities remain properly documented, traceable, completed within established timelines, technically supported, and maintained in a state of GMP and regulatory inspection readiness.
