Maintenance Documentation & Qualification Specialist
Technical & Engineering Consulting, Barceloneta, Barceloneta, United States
Overview:
We are seeking an experienced
Maintenance Documentation & Qualification Specialist
to support regulated manufacturing operations. This role will be responsible for
equipment qualifications, generation of procedures, and management of maintenance documentation , including
Preventive Maintenance (PM), Calibration, and Spare Parts/Stock items .
The ideal candidate brings hands‑on experience in
GMP environments , strong documentation skills, and the ability to ensure compliance with regulatory and internal standards.
Key Responsibilities:
Lead and support
equipment qualification activities
(IQ/OQ/PQ as applicable)
Develop, review, and update
standard operating procedures (SOPs)
and maintenance procedures
Manage and maintain documentation for:
Preventive Maintenance (PM)
Calibration programs
Spare parts / stock items
Ensure all documentation complies with
GMP, FDA, and internal quality standards
Support
maintenance systems (CMMS)
for tracking PMs, calibrations, and inventory
Collaborate with Engineering, Maintenance, and Quality teams
Support
audit readiness
and respond to internal/external audits
Assist in
deviations, investigations, and CAPA implementation
related to maintenance activities
Ensure proper
data integrity and documentation control practices
Identify opportunities for process improvements in maintenance documentation and systems
Qualifications:
Bachelor’s degree in
Engineering, Science, or related field
(or equivalent experience)
3–7+ years of experience
in regulated industries (Pharma, Biotech, Medical Devices)
Strong experience in:
Equipment Qualifications (IQ/OQ/PQ)
SOP generation and document control
Maintenance systems (PM, Calibration, Inventory)
Experience with
CMMS systems
(Maximo, SAP, etc.) preferred
Knowledge of
GMP, FDA regulations, and data integrity principles
Strong attention to detail and documentation skills
Bilingual (English/Spanish) preferred
Preferred Skills:
Experience in
utilities and manufacturing equipment
Exposure to
calibration standards and asset management systems
Familiarity with
change control (MOC)
processes
Ability to work in fast‑paced, cross‑functional environments
What We Offer:
Opportunity to work on
high‑impact projects in regulated industries
Dynamic and collaborative environment
Competitive compensation based on experience
Fast‑moving team with strong industry presence
#J-18808-Ljbffr
Maintenance Documentation & Qualification Specialist
to support regulated manufacturing operations. This role will be responsible for
equipment qualifications, generation of procedures, and management of maintenance documentation , including
Preventive Maintenance (PM), Calibration, and Spare Parts/Stock items .
The ideal candidate brings hands‑on experience in
GMP environments , strong documentation skills, and the ability to ensure compliance with regulatory and internal standards.
Key Responsibilities:
Lead and support
equipment qualification activities
(IQ/OQ/PQ as applicable)
Develop, review, and update
standard operating procedures (SOPs)
and maintenance procedures
Manage and maintain documentation for:
Preventive Maintenance (PM)
Calibration programs
Spare parts / stock items
Ensure all documentation complies with
GMP, FDA, and internal quality standards
Support
maintenance systems (CMMS)
for tracking PMs, calibrations, and inventory
Collaborate with Engineering, Maintenance, and Quality teams
Support
audit readiness
and respond to internal/external audits
Assist in
deviations, investigations, and CAPA implementation
related to maintenance activities
Ensure proper
data integrity and documentation control practices
Identify opportunities for process improvements in maintenance documentation and systems
Qualifications:
Bachelor’s degree in
Engineering, Science, or related field
(or equivalent experience)
3–7+ years of experience
in regulated industries (Pharma, Biotech, Medical Devices)
Strong experience in:
Equipment Qualifications (IQ/OQ/PQ)
SOP generation and document control
Maintenance systems (PM, Calibration, Inventory)
Experience with
CMMS systems
(Maximo, SAP, etc.) preferred
Knowledge of
GMP, FDA regulations, and data integrity principles
Strong attention to detail and documentation skills
Bilingual (English/Spanish) preferred
Preferred Skills:
Experience in
utilities and manufacturing equipment
Exposure to
calibration standards and asset management systems
Familiarity with
change control (MOC)
processes
Ability to work in fast‑paced, cross‑functional environments
What We Offer:
Opportunity to work on
high‑impact projects in regulated industries
Dynamic and collaborative environment
Competitive compensation based on experience
Fast‑moving team with strong industry presence
#J-18808-Ljbffr