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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in commercial drug product manufacturing operations, including formulation, filling, and lyophilization, while ensuring compliance with GMP regulations. Proficient in troubleshooting, equipment maintenance, and leading validation programs to support operational excellence.
Highest-signal resume keywords
GMP ComplianceProcess EngineeringEquipment MaintenanceTroubleshootingProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
FormulationFillingLyophilizationTechnical Protocol AuthoringQuality InvestigationsChange ControlValidationRoot Cause IdentificationSterile ManufacturingPilot Plant Operations
Soft Skills
Problem-SolvingOrganizational SkillsCollaborationCommunication
Tools & Technologies
Electronic Batch RecordsAutomation SystemsData Visualization Solutions
Industry Keywords
GMPRegulatory CertificationDeviation InvestigationsCAPA ImplementationCommissioningQualificationSafety Compliance
About the role
Key responsibilities & impact- Initially support business needs at the Durham, North Carolina site for approximately 12–18 months, then relocate to Rahway, New Jersey based on business needs
- Provide on-site support for commercial drug product manufacturing operations, including formulation, filling, lyophilization, and visual inspection
- Troubleshoot shop-floor equipment and automation
- Support deviation investigations, change controls, equipment validation, technical protocol authoring and execution, and equipment maintenance
- Serve as technical SME for formulation, process development, scale-up, equipment troubleshooting, and maintenance
- Author quality investigations, change controls, SOPs, technical protocols, and validation documents
- Contribute to commissioning, qualification, and regulatory certification of the FLEx Sterile GMP clinical manufacturing facility
- Collaborate with formulation scientists, engineers, quality representatives, manufacturing, facilities, IT, and external vendors
- Support aseptic drug product formulation, filling, and lyophilization operations
- Manage project assignments and support facility and process equipment innovation
- Perform manual and/or automated operations, general maintenance, troubleshooting, and support functions
- Lead sterilization and cleaning validation programs, technical assessments, and regulatory inspection support
- Own change management, periodic reviews, deviation investigations, root cause analyses, and CAPA implementation
- Maintain GMP-compliant facilities, utilities, manufacturing equipment, automation systems, documentation, and configurations
- Support capital projects and new product introductions, including automation design, integration, FAT/SAT, commissioning, qualification, and acceptance testing
- Develop data, reporting, and visualization solutions to drive operational excellence and continuous improvement
- Manage work orders, contractors, purchase orders, budgets, asset tracking, and project closeout activities
Requirements
What you’ll need- B.S. Degree in Chemical/Bio-Chemical Engineering or Chemistry/Biological Sciences or related disciplines
- Minimum of 2 years of relevant experience
- Familiarity with United States and European Union GMP and safety compliance regulations
- Strong problem-solving skills and ability to work independently
- Strong organizational skills with ability to manage multiple priorities and deadlines
- Ability to collaborate effectively with cross-functional teams and stakeholders
- Excellent verbal and written communication skills
- Electronic Batch Records
- Equipment Maintenance
- Operation Maintenance
- Pilot Plant Operations
- Process Engineering
- Process Manufacturing
- Product Formulation
- Root Cause Identification
- Sterile Manufacturing
- Troubleshooting
- No visa sponsorship
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Domestic relocation
- 10% travel