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Project Engineer 2

Company: Biomarin
Location: Novato
Posted on: June 12, 2021

Job Description:

Project Engineer 2

Location Novato, California Apply

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients' lives.

SUMMARY

The Project Engineer 2 will be responsible for driving projects to implement new equipment or modify existing equipment for bioprocess manufacturing facilities and corporate facilities. This role will be engineering lead for capital projects and will often have contract engineers report directly to him/her. The role will be responsible for interfacing with the project manager and engineering design firms to ensure requirements are met on schedule and budget. Responsibilities include creating/reviewing design specifications, preparing/reviewing bid packages, managing detailed design review, managing vendor interactions and factory testing, and implementing equipment for the project. These projects may be new process equipment, new facilities/utilities and/or retrofit of existing facilities/utilities. The candidate will be responsible for ensuring all systems comply with the requirements.

As a Project Engineer 2, candidate must have a strong knowledge of biotechnology/pharmaceutical process equipment and / or facilities / utilities. Candidate will also ensure implementation of good engineering practices on all design activities, review and approve design documents, ensure correct process design to cGMPs and all other governing state and local authorities. Support all projects from design through construction, start-up, and commissioning/qualification.

This position will interact collaboratively with key customers, peers and other stakeholders to support achieving BioMarin tactical and strategic goals & objectives.

RESPONSIBILITIES

  • Lead cross functional team to develop user requirements
  • Coordinate engineering activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Quality Control, Quality Assurance, Quality Validation, Capital Project Managers, Facilities and various Engineering groups.
  • Develop Requests for Proposals for contract resources and train contract resources on BioMarin procedures.
  • Demonstrate leadership ability including the ability to lead, motivate, develop and directly/indirectly influence others effectively
  • Employ good document practices (GDP) when drafting and reviewing documents
  • Create and Develop Practice documents and Specifications to support continuous improvement initiatives
  • Apply extensive practical expertise in their area(s) of knowledge
  • Effectively manage internal and external relationships with key stakeholders and vendors
  • Develop and maintain effective communication with peers, subordinates and senior management
  • Demonstrate the ability to be self-directed with limited guidance and oversight from management
  • Effectively apply independent judgment utilizing BioMarin policies, industry practices and BioMarin standards as guidance
  • Demonstrate effective collaboration, partnering and teamwork skills when interacting with internal and external resources
  • Actively participate in technical, tactical and strategic reviews/discussions
  • Remain current on all training requirements

EDUCATION

BS or MS in Engineering from an accredited university.

EXPERIENCE

  • 5+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in capital project engineering
  • Organizational and management skills to coordinate multi-discipline project groups
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Experience with Autocad
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Keywords: Biomarin, Novato , Project Engineer 2, Other , Novato, California

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