- Collaborate engineering activities with cross-functional, multi-departmental teams.
- Lead technical feasibility studies.
- Responsible for developing Requests for Proposals for contract resources and support training 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 and executing protocols.
- 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.
- Provides technical guidance and mentors other engineers
- At least 15 years of working experience in a cGMP regulated environment, with exhibited knowledge or proficiency in capital project engineering.
- Able to develop site and global standards and work processes used to complete capital projects.
- Well-versed in coordinating between tasks of other SMEs and their own expertise
- Develop system risk assessments.
- Leads complex design/review for new applications or technologies.
- Develops design standards and/or participates in internal SME forums.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Create, control and define lifecycle documents and validation testing.
- Experience with AutoCAD, Bluebeam and Adobe Acrobat.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point
- HVAC
- RODI
- WFI
- Mechanical, Electrical Plumbing (MEP)
- Facility Design
- Other utility systems (Boilers, Chillers, Air Compressors)
- CIP/SIP
- Parts Washers
- Sterilizers
- Buffer/Media Prep
- Cell Culture, Fermentation
- Chromatography
- Centrifugation
- TFFEDUCATION
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Sr. Project Engineer 2 - Novato, United States - BioMarin Pharmaceutical Inc.
Description
Who We Are
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.
SR. PROJECT ENGINEER 2SUMMARYThe Sr.
Project Engineer 2 will be responsible for leading all technical aspects on capital projects to implement new equipment or modify existing equipment for bioprocess manufacturing facilities.
This role will be engineering lead and subject mater expert for capital projects and will often have contract engineers report directly to support them.
The role will be responsible for interfacing with project managers and engineering design firms to ensure requirements are met on schedule and budget.
Responsibilities include creating/reviewing user requirement specifications, design specifications, preparing/reviewing bid packages, managing detailed design review, mentoring junior staff, managing vendor interactions and factory acceptance testing, and implementing equipment for the project.
These projects may be new process equipment and/or retrofit of existing equipment. The candidate will be responsible for ensuring all systems comply with the approved user requirements. The Sr. Project Engineer 2 must have a strong knowledge of biotechnology/pharmaceutical process equipment.Candidate will also ensure implementation of good engineering practices on all design activities, review and approve design documents, and is responsible for ensuring correct process design to cGMPs and all other governing state and local authorities.
Supports projects from feasibility through design, 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
EXPERIENCERequired Skills:
Desired Skills:
Subject Matter Expert on three or more of the following equipment or processes:
CONTACTS
Manufacturing, Process Sciences, Quality Control, Commissioning and Qualification, Quality Assurance Validation, Capital Project Managers, Facilities and various internal and external Engineering groups.
SHIFT DETAILS
Day shift Monday-FridayONSITE, REMOTE, OR FLEXIBLE
This position works a flexible work schedule with two onsite days per week (typically Wednesday and one other day). Onsite time fluctuates with the project loads and more onsite time is anticipated during startups.
TRAVEL REQUIRED
Travel for Factory Acceptance Testing is require as needed (typically a week at a time, 2-4 times per year).
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.
