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Process Engineer – Pharmaceutical Manufacturing (Oral Storage Dosage & Sterile)

Interact Engineering LLC
Whippany, NJ

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Job Details

Temporary | Full-time
$42 an hour
12 days ago

Qualifications

Incident investigation techniques for hazard identification
Data integrity assurance
Defect resolution root cause analysis
Engineering testing
Project documentation
Technical documentation
Engineering
Technical writing experience within manufacturing
Production deviation management
Compliance audits & assessments
Corrective and preventive actions (CAPA)
GMP
Project management experience in manufacturing
ICH Q9
Manufacturing facility experience
Data integrity and documentation
Production validation processes
Bachelor's degree
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
ICH Q10
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Data collection
Manufacturing
Legal compliance
Cross-functional communication
Audit support
Engineering validation
Data analysis software

Full Job Description

Process Engineer

POSITION SUMMARY

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.
Support aseptic manufacturing processes for injectable products (syringes, vials, ampoules).
Participate in sterility assurance reviews, environmental monitoring investigations, and media fill evaluations.
Assist with equipment qualification (autoclaves, filling lines, isolators, lyophilizers) in alignment with sterile area validation requirements.

REQUIRED QUALIFICATIONS

Education: Bachelor’s or master’s degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or related field.
Experience:
5–10 years’ experience in pharmaceutical manufacturing, covering both OSD and sterile operations.
Proven track record in process validation, CPV, and equipment qualification.
Experience in root cause investigation, CAPA management, and regulatory audits (FDA, EMA, MHRA).
Exposure to serialization and aggregation systems and related compliance standards.
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

Physical Requirements:

Primarily plant-based role with regular presence on the production floor.
May require support during off-shift or weekend operations depending on project or investigation needs.

Job Types: Full-time, Temporary

Pay: $42.00 per hour

Work Location: In person

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