Responsibilities :
Lead the commissioning and qualification activities for aseptic fill manufacturing equipment, including vial washers, depyrogenation tunnels, isolators, sterile fillers, and cappers.
Develop and execute qualification protocols (IQ / OQ / PQ) in accordance with regulatory requirements (FDA, EMA, etc.) and company standards.
Collaborate with cross-functional teams, including engineering, quality assurance, and production, to ensure successful equipment qualification and seamless integration into manufacturing operations.
Conduct risk assessments and implement appropriate mitigation strategies to ensure the integrity and sterility of the manufacturing process.
Troubleshoot equipment issues and implement corrective and preventive actions (CAPAs) as needed to maintain equipment performance and compliance.
Provide technical expertise and support to manufacturing personnel during routine operations, ensuring adherence to standard operating procedures (SOPs) and best practices for aseptic processing.
Stay current with industry trends, regulations, and advancements in aseptic fill manufacturing technologies, and incorporate best practices into manufacturing processes.
Requirements :
Bachelor's degree in engineering, pharmaceutical sciences, or related field. Advanced degree preferred.
Minimum of 7 years of experience in aseptic fill manufacturing, with a focus on commissioning and qualification of equipment.
Extensive knowledge of regulatory requirements and guidelines governing aseptic processing (e.g., cGMP, Annex 1).
Proven experience in developing and executing qualification protocols (IQ / OQ / PQ) for aseptic fill manufacturing equipment.
Strong analytical and problem-solving skills, with the ability to identify and resolve technical issues in a timely manner.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
Detail-oriented and organized, with a commitment to quality and compliance.
Experience with risk assessment methodologies and implementation of risk-based approaches to equipment qualification and process validation.
Validation Engineer
Collaborate with cross-functional teams, including engineering, quality assurance, and production, to ensure successful equipment qualification and seamless integration into manufacturing operations. Bachelor's degree in engineering, pharmaceutical sciences, or related field. Experience with risk as...
Senior Validation Engineer (No C2C)
Support the Quality Engineering group with documentation and validation needs. Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc. Perform hands on validation execution for automation implementation project. Review and a...
System Validation Engineer
Board/System SW+HW bring up experience.Test functional features of product (e.Any system/board experience is needed.Ability to setup new HW based on instructions, install OS/FWs as needed.Use existing utilities to test functional features of a system.Automate + Integrate those utilities for factory ...
Hardware Validation Engineer
Job Title: Hardware Validation Engineer. Work closely with the R&D, Production, Quality, Engineering, and Production Engineering teams. ...
Senior NPI Quality Engineer-Medical Devices, IQ/OQ/PQ validation
As a Senior New Product Introduction (NPI) Quality Engineer, you will hold a critical position within our New Product Introduction Quality Engineering group, providing indispensable support across both our development and manufacturing areas. Apply engineering principles and quality regulations to d...
Validation Project Engineer II
We are hiring an experienced Validation Project Engineer II. Generate, revise, and manage validation lifecycle documentation including user requirements, functional and design specifications, configuration specifications, computerized systems assessments, asset inductions, and validation protocols a...
Validation Engineer
Collaborate with cross-functional teams, including engineering, quality assurance, and production, to ensure successful equipment qualification and seamless integration into manufacturing operations. Bachelor's degree in engineering, pharmaceutical sciences, or related field. Experience with risk as...
Systems Validation Engineer
The Systems Engineer II participates in the development, verification, and validation of in-vitro diagnostic (IVD) instruments. Bachelor's degree in the field of systems, mechanical, or electrical engineering with a minimum of 2 years of experience, preferably candidates with experience in diagnosti...
Validation Project Engineer II
We are hiring an experienced Validation Project Engineer II. Generate, revise, and manage validation lifecycle documentation including user requirements, functional and design specifications, configuration specifications, computerized systems assessments, asset inductions, and validation protocols a...
Validation Project Engineer II
We are hiring an experienced Validation Project Engineer II. Generate, revise, and manage validation lifecycle documentation including user requirements, functional and design specifications, configuration specifications, computerized systems assessments, asset inductions, and validation protocols a...