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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing capital projects for drug product filling and compounding equipment, ensuring compliance with FDA and EMA regulations while leading multidisciplinary teams. Proficient in project planning, budget management, and technical execution within pharmaceutical manufacturing environments.
Highest-signal resume keywords
Mechanical Engineering DegreePharmaceutical Manufacturing ExperienceProject Budget ManagementFilling And Compounding Systems ExpertiseFDA And EMA Compliance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementMechanical EngineeringProcess EngineeringAseptic FillingLyophilizationVial/Syringe FillingAseptic Compounding SystemsFactory Acceptance Testing (FAT)Site Acceptance Testing (SAT)Equipment Commissioning And Qualification
Soft Skills
LeadershipMentoringCollaborationCommunicationRisk Management
Industry Keywords
GMP RequirementsCapital ProjectsPharmaceutical IndustryGlobal StandardsHealth Authority Requirements
About the role
Key responsibilities & impact- Lead and manage the technical execution of drug product filling and compounding equipment sub-projects
- Plan, design, and implement mechanical and process engineering projects
- Ensure compliance with Roche Guidelines, Global Standards, and Health Authority Requirements
- Manage approved sub-project budgets and schedules
- Define priorities and provide updates on progress, risks, mitigation strategies, and escalations
- Serve as the primary interface with equipment manufacturers
- Manage technical specifications, design reviews, performance validation, and compliance requirements
- Lead and coordinate Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), commissioning, and qualification activities
- Direct and manage external engineering firms, service providers, and contractors
- Guide project scope, options analysis, project planning, detailed scheduling, and resource allocation
- Mentor and coach less experienced engineers
- Collaborate with global stakeholders and multidisciplinary project teams to deliver capital projects for pharmaceutical manufacturing
Requirements
What you’ll need- Bachelor’s Degree in Mechanical Engineering, Chemical Engineering, or a related discipline with 8+ years of experience, or a Master’s Degree with 6+ years of experience in pharmaceutical/biopharmaceutical filling and compounding equipment
- An MS in Engineering and/or an MBA is preferred
- Extensive experience in international management of capital projects related to drug product filling and compounding equipment
- Experience with typical project budgets ranging from 18 to 60 M USD
- 8+ years of specific operational experience with filling and compounding systems and equipment, including aseptic filling, lyophilization, vial/syringe filling, and aseptic compounding systems
- Proven experience collaborating with equipment manufacturers
- Experience leading FAT/SAT efforts
- Experience managing equipment commissioning and qualification activities
- Significant knowledge of FDA and EMA regulatory compliance and GMP requirements
- Experience delivering complex projects in pharmaceutical manufacturing environments
- Significant travel (50%+), including weekly commuting and/or temporary remote assignments as required
- Availability for international project assignments of 1 to 3 years as required
- Ability to work on-site; no remote options are available
- Must meet applicable work authorization and legal requirements implied by employment in the United States
Benefits
Comp & perks- A discretionary annual bonus may be available based on individual and Company performance
- Benefits detailed in the linked benefits information
- Relocation benefits are not approved for this posting