USA-Process Engineer III (Engineering)

Katalyst CRO; Morristown (NJ); On-site; USD 75,000 - 110,000; Full time

Job summary

An established industry player is seeking a Process Engineer III to support critical packaging processes and regulatory compliance in the pharmaceutical sector. This role involves collaborating with various teams to develop strategies for product development, qualification, and launch. You will lead projects, provide technical recommendations, and enhance processes to improve quality and compliance. If you are passionate about driving innovation in pharmaceutical manufacturing and have strong project management skills, this is an exciting opportunity to make a significant impact.

Qualifications

• Bachelor's degree in Process/Package Engineering required.
• Strong project management skills with experience in multi-functional teams.

Responsibilities

• Support technical documentation and internal systems for packaging processes.
• Collaborate with multi-functional teams to develop project strategies.

Skills

Project Management

Technical Writing

Packaging Materials Knowledge

Regulatory Compliance Awareness

Communication Skills

Education

Bachelor's Degree in Process/Package Engineering

Advanced Degree in Process/Package Engineering

Tools

MS Office

Job description

Join to apply for the USA-Process Engineer III (Engineering) role at Katalyst CRO

Support activities within MSAT-US regarding technical documentation, SOPs, and internal systems.

Develop technical positions on packaging and Pharma processes, equipment, materials, and regulatory compliance for client packaging practices. Investigate and recommend new processes, technologies, systems, and materials for potential integration into manufacturing systems.

Provide technical and project management support for CMC and packaging projects supporting late-stage NCE development, Life Cycle Management Programs (LCM), and Commercial Products.

Support multi-functional teams to formulate plans and strategies that meet objectives.

Collaborate with R&D Drug Development, iCMC, IA packaging sites, suppliers, Regional Marketing, Regulatory, Supply Chain, and QA to develop project strategies and objectives.

Lead or support qualification (IOQ/PPQ) of process, packaging, and equipment.

Support qualification of transport systems for bulk/intermediates and finished products.

Make technical and business recommendations for pharma and packaging processing supporting product development.

Develop test protocols and manage execution of studies including transport qualification.

Act as technical and coordination focal point for sites and external CMOs for multi-site projects, and act as Project Manager when needed.

Identify new processes and technologies to improve cost, compliance, quality, and customer acceptance.

Represent Manufacturing & Supply in product development, qualification, dossier preparation, and launch. Participate in project teams, Tech Transfer Teams, Launch Teams, and Packaging Task Forces.

Support evaluations of primary packaging materials and make equipment recommendations based on product protection, performance, and cost.

Identify new technologies and applications to enhance industry positioning for Client.

Requirements:

• Bachelor's or advanced degree in Process/Package Engineering.
• Strong project management skills with experience in multi-functional teams.
• Knowledge of solid and liquid oral processes, packaging materials, and their performance characteristics.
• Understanding of packaging testing principles per USP, ASTM, ISTA, IATA, CFR, FDA.
• Awareness of pharmaceutical supply, distribution, and regulatory requirements.
• Proficiency with MS Office; experience in technical writing.
• Excellent English verbal and written communication skills.
• Experience in equipment start-up, qualification, and validation.

Additional Details:

• Seniority level: Associate
• Employment type: Contract
• Industry: Pharmaceutical Manufacturing