The
Process Engineer
is responsible for ensuring the reliability, compliance, and performance of manufacturing processes, equipment, utilities, and computerized systems within a pharmaceutical or biotechnological environment. This role requires strong expertise in
process engineering
,
computer system validation
, and
technical troubleshooting
, supporting daily operations and continuous improvement initiatives to maintain regulatory compliance and operational excellence.
Provide
day‑to‑day troubleshooting
for manufacturing equipment, automated systems, utilities, and process deviations to ensure uninterrupted operations.
Lead and execute the
Computer Validation Life Cycle (CVLC)
for systems such as SCADA, PLCs, smart instruments, and networked control systems.
Develop and execute
FAT, IQ, OQ, and PQ
protocols, including preparation of qualification reports and supporting documentation.
Prepare and maintain
SOPs
, disaster recovery plans, backup strategies, and system configuration documentation.
Conduct
Quality Risk Assessments
and
Qualification Risk Assessments
for equipment, utilities, and computerized systems.
Support and manage engineering and validation activities for
facility expansions
, new equipment installations, and system upgrades.
Perform
commissioning, start‑up, and qualification
of critical utilities including HVAC, compressed air, purified water systems, and facility infrastructure.
Participate in investigations,
CAPA development
, and root cause analysis for process, equipment, and system failures.
Review engineering drawings, P&IDs, material certifications, welding documentation, and construction packages for compliance and technical accuracy.
Collaborate in
HAZOP
, hazard analyses, and safety assessments for new and existing systems.
Develop and maintain
Calibration Programs
, HEPA filter certification processes, and software control systems.
Prepare
Validation Master Plans
, analytical reports, and regulatory documentation to support audits and inspections.
Work closely with cross‑functional teams including Manufacturing, Quality Assurance, Engineering, and Automation to ensure process robustness and compliance.
Requirements
Bachelor’s degree in Engineering (Chemical,
Mechanical, Electrical, Industrial, Biomedical, or related field).
Extensive experience in
process engineering
,
validation
,
metrology
, and
quality assurance
within
pharmaceutical or biotech manufacturing.
Strong knowledge of
21 CFR Part 11
,
GAMP
,
and validation of automated systems (SCADA, PLCs, HVAC, water systems,
utilities).
Demonstrated ability to perform
technical
troubleshooting
on equipment and computerized systems.
Experience in project management, facility start‑ups,
equipment commissioning, and system upgrades.
Proficiency in developing protocols, SOPs, risk
assessments, and validation documentation.
Experience with investigations, deviations, and
CAPA management.
Strong communication, teamwork, and leadership
skills.