HCG Process Engineer - Pharmaceutical Manufacturing

We are seeking a highly skilledand motivated Process Engineer to join our pharmaceuticalmanufacturing team. The Process Engineer will play a crucial rolein optimizing manufacturing processes ensuring product quality andimproving operational efficiency.

This position requires a deepunderstanding of pharmaceutical manufacturing principles processengineering and regulatorycompliance.

Key Responsibilities

ProcessOptimization :

• Develop evaluate and optimize manufacturing processesto enhance efficiency quality andcosteffectiveness.
• Identify and implement process improvements to reducewaste increase yield and improve overall productionperformance.

QualityAssurance :

• Ensure all manufacturing processes comply with GoodManufacturing Practices (GMP) regulatory standards and companyquality policies.
• Conduct root cause analysis and corrective actions forprocess deviations andnonconformances.

TechnicalSupport :

• Provide technical support to production teamstroubleshoot processrelated issues and recommendsolutions.
• Collaborate with R&D Quality Control and otherdepartments to ensure smooth technology transfer and processvalidation.

Documentation andCompliance :

• Prepare and maintain detailed documentation includingStandard Operating Procedures (SOPs) process flow diagrams andvalidation protocols.
• Ensure compliance with all regulatory requirementsincluding FDA EMA and other relevantagencies.

ProjectManagement :

• Lead or participate in crossfunctional project teams todevelop and implement new processes equipment andtechnologies.
• Manage project timelines budgets and resourceseffectively to ensure successful projectcompletion.

Continuous Improvement :

• Drivecontinuous improvement initiatives by implementing LeanManufacturing Six Sigma and othermethodologies.
• Conduct regular process audits and reviews to identifyareas for improvement and implement bestpractices.

Requirements

Education : Bachelor s or Master s degree inChemical Engineering Biochemical Engineering PharmaceuticalEngineering or a related field.

Experience :

• Minimum of5 years of experience in process engineering within apharmaceutical manufacturingenvironment.
• Experience with process optimization scaleup andvalidation in a GMPregulatedsetting.
• Strong background working with Emerson DCS SCADASiemens or Allen Bradley PLCs MES LIMS BMSERPs
• Excellent communication and interpersonal skills tocollaborate effectively with crossfunctionalteams.
• Knowledge of regulatory requirements and qualitysystems in the pharmaceuticalindustry.
• Ability to manage multiple projects and prioritizetasks in a fastpacedenvironment.

PreferredQualifications

Certified Lean Six Sigma Green Belt or BlackBelt.

BS Engineering (orequivalent experience) 2+ years working Automation experience inthe Pharmaceutical Industry (preferable in API / bulk manufacturing)Previous Pharmaceutical Automation Project experience including : Deriving S88 physical model from P&IDs Deriving softwarecontrol strategies from PFDs and related process documents DeltaVDCS implementation exposure / experience Exceptional teamworkabilities Strong knowledge of GMP s, regulatory requirements andcomputer system validation principles Excellent written and verbalcommunication skills for both technical and non-technicalaudiences