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Sr Manufacturing Engineer

Los Altos Hills, CA 94022

Posted: 08/20/2024 Employment Type: Contract Job Category: Engineering Job Number: 614025 Is job remote?: No Country: United States

Job Description


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

 

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.

 

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Los Altos Hills, CA

Ready to take your career to new heights? Explore job opportunities in the vibrant area surrounding Los Altos Hills, California! Nestled in the heart of Silicon Valley, this region offers unparalleled growth potential and a thriving tech industry. From the stunning views of the Santa Cruz Mountains to the innovative energy of Stanford University nearby, this area has it all. Indulge in the farm-to-table cuisine at local eateries or explore the art galleries and theaters in nearby Palo Alto. With easy access to outdoor adventures at Rancho San Antonio County Park and the excitement of professional sports teams in San Francisco, Los Altos Hills is a perfect blend of work and play. Start your job search today and unlock a world of possibilities in this dynamic location!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.