Sr Manufacturing Engineer NPD Job at Entegee in Menlo Park
Entegee, Menlo Park, CA, US
Job Description
Job Summary: Lead and coordinate manufacturing activities for pharmaceutical product development, including new product and process development, equipment validation, and quality systems management.
Job Requirements:
Bachelor's Degree in Chemical Engineering, Biomedical Engineering, or Mechanical Engineering.
5+ years of experience in pharmaceutical product manufacturing and pharmaceutical quality systems.
Experience with new product and process development, including equipment and process validations.
Experience coordinating and leading manufacturing builds.
Preferred Skills:
Experience with biodegradable polymers and drug/device combination products.
Proficiency in drug coating processing, such as spray coating and dip coating.
Strong organizational and operational skills with attention to detail and the ability to manage multiple projects simultaneously.
Job Responsibilities:
Participate in and contribute to the new product development of pharmaceutical drug products in alignment with the company's strategic plan.
Lead manufacturing engineering activities related to planning and executing builds and experiments for product development, process integration, and equipment qualification.
Support the development of the Pharmaceutical Quality System from a manufacturing engineering perspective.
Coordinate and manage manufacturing activities for product development batches, including engineering, qualification, and clinical builds.
Own and execute equipment qualification, maintenance, and calibration activities.
Collaborate with supply chain management for materials issuance for development and clinical builds.
Support cleanroom and cleaning qualification activities.
Own and support Master Validation Plans to ensure alignment between operations and the core team for sustainable commercial manufacturing.
Provide indirect management for assemblers and technicians conducting manufacturing operations.
Gather and manage manufacturing requirements to meet project timelines and collaborate with team members and stakeholders.
Design manufacturing processes, procedures, and production layouts to ensure efficiency and productivity.
Inspect machinery, equipment, and tools for performance, initiating corrective actions as needed to ensure product quality.
Pay: 55-65
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.
Pay Details: $55.00 to $65.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.