Overview
On Site
Full Time
Skills
Management
Risk Assessment
FMEA
GxP
Traceability Matrix
SCADA
Collaboration
Process Engineering
System Integration
System Administration
Regulatory Compliance
Auditing
Documentation
Electrical Engineering
Mechanical Engineering
Computerized System Validation
Pharmaceutics
Medical Devices
Document Management
URS
IQ
OQ
PQ
HVAC
GAMP
Technical Writing
Problem Solving
Conflict Resolution
Communication
Manufacturing
API
MES
LIMS
GMP
Job Details
Responsibilities:
- Validation & Documentation.
- Author, review, and execute validation documentation including User Requirement Specifications (URS), Functional Specifications, Design Qualification (DQ), FAT, SAT, IQ, OQ, and PQ.
- Manage validation lifecycle documentation using Kneat.
- Perform risk assessments (FMEA, GxP impact assessments, traceability matrices.)
- Automation Systems (DeltaV & others.)
- Support automation projects involving DeltaV Distributed Control Systems (DCS), PLCs, and SCADA systems.
- Collaborate with automation and process engineering teams to ensure system integration, configuration, and qualification.
- Troubleshoot and support control system operations during commissioning and validation.
- Equipment & Utility Validation.
- Execute validation protocols for GMP manufacturing equipment, laboratory instruments, facilities, and utilities (e.g., purified water, clean steam, HVAC, compressed gases.)
- Support equipment qualification from FAT/SAT through operational readiness.
- Ensure systems meet regulatory requirements (FDA, EMA, ICH, Annex 11, 21 CFR Part 11.)
- Compliance & Quality.
- Ensure adherence to company quality standards and global regulatory requirements.
- Support audits and inspections by providing validation and automation documentation.
- Drive continuous improvements in validation strategies and procedures.
- Bachelor's degree in engineering (Automation, Electrical, Mechanical, Chemical, or related field.)
- 3-7+ years of experience in automation engineering, CSV, or equipment validation within a GMP-regulated environment (biotech/pharma/medical device.)
- Proficiency with Kneat Gx for electronic validation document management.
- Hands-on experience with DeltaV DCS and automation systems.
- Strong knowledge of validation lifecycle (URS, DQ, FAT, SAT, IQ/OQ/PQ.)
- Familiarity with facilities & utilities systems (water systems, clean utilities, HVAC.)
- Strong understanding of GAMP 5, 21 CFR Part 11, Annex 11, and FDA/EMA guidelines.
- Excellent technical writing, problem-solving, and communication skills.
- Experience in biologics, sterile manufacturing, or API facilities.
- Knowledge of MES, LIMS, and other GMP computerized systems.
- Prior involvement in CQV projects and capital projects.
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