A contract development and manufacturing organization that specializes in producing topical, semi-solid, and liquid pharmaceutical products for both prescription and over-the-counter markets. It supports clients through formulation, scale-up, manufacturing, and packaging, with a strong focus on quality, regulatory compliance, and speed to market.
POSITION SUMMARY
Process Engineer - Pharmaceutical Manufacturing (Hybrid:
OSD & Sterile)
The Process Engineer is responsible for driving process robustness, compliance, and performance improvement
across both Oral Solid Dosage (OSD) and Sterile (vials, syringes, liquids) manufacturing operations. This role
plays a key part in investigations, process validation, continuous process verification (CPV), and equipment
lifecycle management. The engineer will lead initiatives in Operational Excellence, reliability engineering, and
serialization and aggregation implementation to ensure consistent product quality and manufacturing efficiency.
ESSENTIAL FUNCTIONS
* Lead and execute technical investigations related to process deviations, out-of-trend (OOT) results, and
equipment performance issues.
* Apply root cause analysis (RCA) and develop effective CAPAs to prevent recurrence.
* Perform process risk assessments (FMEA, HACCP) and ensure alignment with QbD and control
strategy principles.
* Support data trending, process monitoring, and process improvement using statistical and analytical
tools.
* Develop and maintain CPV programs for commercial products across OSD and sterile manufacturing.
* Monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) to ensure continued
process capability and product quality.
* Generate annual CPV reports and present findings to cross-functional and regulatory audit teams.
* Plan, execute, and document equipment qualification (IQ, OQ, PQ) and process validation activities.
* Support introduction of new equipment, process modifications, and technology transfers.
* Collaborate with Engineering, Maintenance, and QA to ensure all equipment and systems remain in a
qualified state throughout their lifecycle.
* Lead and support Operational Excellence initiatives utilizing Lean, Six Sigma, and Kaizen
methodologies.
* Implement reliability engineering principles (RCM, Weibull analysis, FMEA) to enhance equipment
uptime and process stability.
* Identify and execute cost-reduction and yield-improvement projects while maintaining compliance and
product quality.
* Manage process and equipment lifecycle activities from design through decommissioning.
* Evaluate process capability and equipment performance to recommend improvements or upgrades.
* Collaborate with global engineering and manufacturing teams on lifecycle and asset management
strategies.
* Provide technical expertise for serialization and aggregation processes within OSD packaging
operations.
* Ensure proper integration and qualification of serialization systems (hardware/software) with production
and ERP systems.
* Support regulatory compliance for traceability and product integrity requirements.
REQUIRED QUALIFICATIONS
* Education: Bachelor"s or master"s degree in Chemical Engineering, Mechanical Engineering,
Pharmaceutical Engineering, or related field.
* Experience:
o 5-10 years" experience in pharmaceutical manufacturing, covering both OSD and sterile
operations.
o Proven track record in process validation, CPV, and equipment qualification.
o Experience in root cause investigation, CAPA management, and regulatory audits (FDA, EMA,
MHRA).
o Exposure to serialization and aggregation systems and related compliance standards.
o Working knowledge of reliability engineering and Operational Excellence tools.
Key Skills & Competencies:
* Strong analytical and problem-solving capabilities with proficiency in tools such as Minitab, MS
Project, MS Tools, etc.
* Solid understanding of cGMP, ICH Q8-Q10, Annex1, 21CFR 210/211/820, ISO 13485 and data
integrity principles.
* Excellent communication, presentation, and technical writing skills.
* Ability to work cross-functionally and manage multiple projects simultaneously.
* Self-motivated, detail-oriented, and committed to continuous improvement.
Preferred Certifications:
* Lean Six Sigma Green Belt / Black Belt
* Certified Reliability Engineer (CRE)
* PMP (Project Management Professional) - desirable
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