Automation Engineer - Biologics Manufacturing
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Gilead Sciences is seeking experienced and knowledgeable Manufacturing Engineers to support our Biopharmaceutical Development and Production site in Oceanside, California. The Manufacturing Engineering role will support utilities, manufacturing, and lab instrumentation so the plant can continue to reliably produce therapeutics and complete successful development runs.
Specific Responsibilities and Skills:
* Practical knowledge of GMP, GAMP5 software development lifecycle (SDLC) and experience in the generation of controlled documents
* Experience creating, updating and maintaining engineering functional specifications design documents and standard operating procedures (SOP)
* Experience with Emerson DeltaV Distributed control system (DCS), hardware wiring, applying ISA S88 programming and system infrastructure
* Experience in Virtualization (Hyper-V), DeltaV Virtual Studio, server configuration, networking, security and storage etc.
* Experience with Allen Bradley/Siemens PLC, FactoryTalk View, FactoryTalk Batch, OPC Communication Applications
* Experience in Building Management System, preferred Siemens Apogee or Desigo
* Demonstrated experience with change control, CAPA and deviation quality systems
* Experience in OSISoft PI, Process book, PI Event Frames (EF), Asset Framework (AF)
* Must have familiarity with Computer System Validation methodology, 21 CFR Part 11 and qualifications (IQ/OQ/PQ)
* Ability to work independently and in cross-functional teams
* Excellent communication and technical writing skills
ESSENTIAL DUTIES AND JOB FUNCTIONS
* Works on the design, modifications, and maintenance of manufacturing equipment, Manufacturing and processes.
* Works on engineering planning, financial justification, start-up activities, scale-up processes, implementation, process improvements, and validation.
* Performs evaluation studies and trouble shooting on manufacturing equipment and systems.
* Generates and reviews required engineering and manufacturing documentation.
* Provides accurate budget estimates for capital equipment and projects.
* Independently resolves manufacturing engineering issues of complex scope.
* Independently manages assigned projects through completion.
* Participates on cross-functional project teams.
* May coordinate contract personnel through completion of assignments; may provide guidance to other manufacturing process engineers.
* Purchases machinery, equipment, tools, raw materials, packaging materials, parts, services, and supplies necessary for the operation of a pharmaceutical organization.
* Compiles and analyzes statistical data to determine the feasibility of buying products and to establish price objectives.
* Compiles information from periodicals, catalogs, and other sources to keep informed on price trends and manufacturing processes.
* Confers with vendors and analyzes vendors' operations to determined factors that affect prices and determines lowest cost consistent with quality, reliability, and ability to meet required schedules.
* Reviews proposals, negotiates prices, selects or recommends suppliers, analyzes trends, follows up order placed, verifies delivery, approves payment, and maintains necessary records.
* Utilizes as necessary, established precedents and policies.
KNOWLEDGE, EXPERIENCE AND SKILLS
* Demonstrates working understanding and application of Engineering principles, concepts, practices, and standards, along with full working knowledge of industry practices.
* Demonstrates working knowledge in aseptic processes, process controls, and equipment design.
* Is able to develop solutions to semi-complex problems.
* Demonstrates strong verbal, written and interpersonal communication skills.
* Demonstrates knowledge of UBC, UFC, NEC codes.
* 6+ years of relevant experience and a BS in engineering.
* 4+ years of relevant experience and a MA/MBA.
* Previous experience in biotech or pharmaceuticals industry desirable.
* Previous experience in engineering in highly regulated manufacturing environments desirable.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
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