Senior Manufacturing Engineer

Job Title : Sr Manufacturing Engineer

Job Location : Menlo Park, California(Fully Onsite)

Type : W2 Contract

Required Skills :

Experience with Pharmaceutical Product manufacturing and pharmaceutical quality systems.

Experience with new product and process development including equipment and process validations

Experience coordinating / leading manufacturing builds

Must Have : Minimum Requirements

Bachelor’s degree required in chemical engineering, biomedical engineering, or mechanical engineering

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.

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.

Ensure processes and procedures are in compliance with regulations.