1 Senior Process Engineer - Pharmaceutical Packaging Development Job in Bridgewater, NJ
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Senior Process Engineer - Pharmaceutical Packaging Development
$120k-142k (estimate)
Contractor
1 Week Ago
CONFLUX SYSTEMS is Hiring a Senior Process Engineer - Pharmaceutical Packaging Development Near Bridgewater, NJ
DescriptionThis role is situated within the Package Development-MSAT (Process Science in Global Manufacturing Science & Technology) functional area. The primary responsibilities encompass making technical and business-based recommendations on packaging systems and materials for both new and marketed pharmaceutical product projects. You will develop test protocols and manage the execution of various packaging studies, including USP, EP, and transport qualification for bulk and finished drug products.
You will act as the technical and coordination focal point for site and external CMOs on multi-site projects, defining development activities and project plans to meet established objectives. As a project manager, you will oversee all technical packaging requirements for the successful introduction of packages from development stages to the commercial market.
Responsibilities
You will act as the technical and coordination focal point for site and external CMOs on multi-site projects, defining development activities and project plans to meet established objectives. As a project manager, you will oversee all technical packaging requirements for the successful introduction of packages from development stages to the commercial market.
Responsibilities
- Identify new packaging technologies and applications that enhance cost, compliance, quality, and customer acceptance.
- Develop process design basis, including sizing and selection of equipment, mass balance, URS, and instrumentation for robust process control.
- Provide input to industrialization strategies and rationale for critical process parameters.
- Serve as a Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
- Lead and supervise groups in the planning of engineering, investigational, definition, and process validation runs.
- Document and interpret study results with recommendations.
- Execute life-cycle design and industrialization of upstream processes and associated test methods for Phase 3 and licensed products.
- Partner with engineering to ensure the industrial implementation of process design, including reviewing engineering design documents.
- Provide technical assistance to manufacturing and quality operations for process troubleshooting and health authority inspections.
- Bachelor's Degree in Packaging Science, Chemical Engineering, Biochemical Engineering, Chemistry, or Mechanical Engineering.
- 5 years of experience in package development/engineering or R&D, preferably in pharma or consumer goods.
- Expertise in one or more upstream process unit operations typically used in biotech/vaccine manufacturing.
- Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, and Process Control Strategies.
- Strong analytical skills for troubleshooting and root cause analysis.
- Excellent verbal and written English skills for technical discussions and presentations.
- Strong project management experience.
- Strong technical writing skills.
- Proficiency with MS Office tools, particularly for authoring Technical Packaging Reports.
- Familiarity with software such as AutoCAD, process simulation/scheduling, and CFD is preferred.
- Experience in equipment start-up, qualification, and validation is preferred.
Job Summary
JOB TYPE
Contractor
SALARY
$120k-142k (estimate)
POST DATE
09/07/2024
EXPIRATION DATE
10/03/2024
WEBSITE
conclavia.net
HEADQUARTERS
Cumming, GA
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