Sr Manufacturing Engineer - Exempt - LanceSoft Inc
Menlo Park, CA 94025
About the Job
HM's Top Needs:
1. Experience with Pharmaceutical Product manufacturing and pharmaceutical quality systems
2. Experience with new product and process development including equipment and process validations
3. Experience coordinating/leading manufacturing builds
Education Required:
Bachelor’s Degree in chemical engineering, biomedical engineering, or mechanical engineering
Years’ Experience Required:
Minimum of 5 years of relevant experience, or minimum of 3 years of relevant experience with an advanced degree
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hrs/week
A Day in the Life
Participate and contribute towards new product development of pharmaceutical drug product in support of company’s strategic plan. In this role, the candidate will be responsible for the overall operations and manufacturing engineering activities related to planning and execution of builds and experiments intended for product development, new process and equipment integrations, equipment qualification, validation master plan, process risk assessments etc.
Responsibilities may include the following and other duties may be assigned.
Support development of Pharmaceutical Quality System from a Manufacturing Engineering Perspective
Own/Coordinate overall Manufacturing activities for product development batches/builds
Own initiation, execution, closure of build packets (engineering, qualification, and clinical batches)
Own equipment qualification activities
Own/Coordinate equipment maintenance and calibration activities with onsite maintenance group
Collaborate with supply chain and manage materials issuance for development and clinical builds
Support facility cleanroom qualification activities
Support cleaning qualification activities
Own/Support Master Validation Plans
Ensure alignment between Operations and Core Team with a vision for long-term sustainable commercial manufacturing of the product
Provide indirect people management including assemblers and technicians who conduct manufacturing operations for the builds
Gather and manage manufacturing related requirements to ensure they meet project and timeline needs and collaborate with team members and key stakeholders
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Develops manufacturing processes that are applicable to statistical process control
Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Ensures processes and procedures are in compliance with regulations.
Must Have: Minimum Requirements
Bachelor’s degree required in chemical engineering, biomedical engineering, or mechanical engineering
100% on-site presence required
Requires a University Degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
Experience with new product and process development including validations and commercial launch
Experience working with biodegradable polymers and drug/device combination products (polymer-based combination drug products intended for sustained/controlled drug release).
Drug coating processing experience (spray coating, dip coating) required.
Excellent organizational and operational skills including attention to detail and documentation, the ability to learn quickly, and the ability to manage multiple projects and multiple tasks simultaneously.
1. Experience with Pharmaceutical Product manufacturing and pharmaceutical quality systems
2. Experience with new product and process development including equipment and process validations
3. Experience coordinating/leading manufacturing builds
Education Required:
Bachelor’s Degree in chemical engineering, biomedical engineering, or mechanical engineering
Years’ Experience Required:
Minimum of 5 years of relevant experience, or minimum of 3 years of relevant experience with an advanced degree
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hrs/week
A Day in the Life
Participate and contribute towards new product development of pharmaceutical drug product in support of company’s strategic plan. In this role, the candidate will be responsible for the overall operations and manufacturing engineering activities related to planning and execution of builds and experiments intended for product development, new process and equipment integrations, equipment qualification, validation master plan, process risk assessments etc.
Responsibilities may include the following and other duties may be assigned.
Support development of Pharmaceutical Quality System from a Manufacturing Engineering Perspective
Own/Coordinate overall Manufacturing activities for product development batches/builds
Own initiation, execution, closure of build packets (engineering, qualification, and clinical batches)
Own equipment qualification activities
Own/Coordinate equipment maintenance and calibration activities with onsite maintenance group
Collaborate with supply chain and manage materials issuance for development and clinical builds
Support facility cleanroom qualification activities
Support cleaning qualification activities
Own/Support Master Validation Plans
Ensure alignment between Operations and Core Team with a vision for long-term sustainable commercial manufacturing of the product
Provide indirect people management including assemblers and technicians who conduct manufacturing operations for the builds
Gather and manage manufacturing related requirements to ensure they meet project and timeline needs and collaborate with team members and key stakeholders
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Develops manufacturing processes that are applicable to statistical process control
Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Ensures processes and procedures are in compliance with regulations.
Must Have: Minimum Requirements
Bachelor’s degree required in chemical engineering, biomedical engineering, or mechanical engineering
100% on-site presence required
Requires a University Degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
Experience with new product and process development including validations and commercial launch
Experience working with biodegradable polymers and drug/device combination products (polymer-based combination drug products intended for sustained/controlled drug release).
Drug coating processing experience (spray coating, dip coating) required.
Excellent organizational and operational skills including attention to detail and documentation, the ability to learn quickly, and the ability to manage multiple projects and multiple tasks simultaneously.
Source : LanceSoft Inc