Project Engineer

DUTIES AND RESPONSIBILITES

• Responsible for elicitation, analysis, and documentation of business requirements.
• Research and exploration of user requirements, costs, and benefits in support of documentation required for the demand management process.
• Responsible for analyzing the business needs to identify new processes and process improvements that will meet those needs.
• Documents current business processes and models to define requirements and/or gaps.
• Analyze detailed system factors including input/output requirements, information and paper flow, hardware, and software needs.
• Analyze "soft" system factors including roles, responsibilities, policy, culture, etc.
• Evaluate the impact of potential software and process changes on the organization.
• Develop and facilitate groups as necessary in pursuit of eliciting and defining requirements.
• Assist in the creation of the business case documentation.
• Understanding of architectural consistency and usability standards.
• Defines and develops user test cases and validates test results during testing.
• Executes unit and functional test cases.
• May conduct system demonstrations and training sessions, as well as participate in design/review of training content.
• Plays a third level support role by helping to troubleshoot and resolve issues with production systems.
• Participates in associate meetings and communicates any concerns to management.

QUALIFICATIONS AND REQUIREMENTS

• Bachelor's degree in computer science, Information Systems, Business, or another related field or equivalent work experience.
• Proven experience leading data migration requirements from legacy systems into a new ERP (Sage X3) environment
• Strong hands-on expertise in requirements elicitation, documentation, and management, with emphasis on data mapping, transformation rules, and validation
• Deep understanding of data structures, data quality, and migration best practices, with the ability to identify gaps and risks early
• Self-driven and accountable professional with strong stakeholder management and communication skills, able to drive outcomes with minimal oversight
• Working knowledge of Confluence and JIRA.
• Experience in any of the following business areas is desired: Sales operations, order entry, accounting, finance, procurement, warehouse operations, order management, and order fulfillment.
• Minimum of 3-5 years' business analysis or systems analysis experience is preferred.

Bonus:

Sage X3 experience (ERP). Associate is expected to operate at a proficient level across the following areas of technical knowledge and skill:

• Ability to organize and prioritize work.
• Detail oriented, proactive, creative, and efficient
• Intermediate level abilities in Excel, Outlook, PowerPoint, Visio, and Word
• Familiarity with application integration methods to include understanding of data mapping process.
• Ability to effectively work both independently and collaboratively in a team environment
• Ability to work on simultaneous and complex projects, with domain expertise in at least one business area.
• Expertise in ERP solution selection and implementation is a plus
• Ability to communicate effectively to both technical and non-technical audiences in written and non-written format
• Ability to work with all levels of associates
• Ability to work with minimal supervision in a very dynamic environment
• Ability to learn new systems and tools
• Knowledge of software development life cycle methodologies, processes, and procedures.
• Active listener
• Effective in a variety of formal/informal presentation settings: one-on-one, small, and large groups.

Job Title:

Project Engineer Location:

Fremont, CA Duration:

6

Months Duties:

The Senior Engineer, Equipment is the Engineering technical lead on the Bulk Drug Substance (BDS), Drug Product (DP) and/or Process Science (PS) systems. This includes but is not limited to Upstream and Downstream BDS, Filling and Packaging equipment. Serve as a primary consultant to troubleshoot equipment/process issues through initial qualification and system release, support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover. Might also own change control and participate in deviation/risk assessment activities. Manage medium in size and complexity equipment related projects. Expected to act as System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area. Technical Expertise Experience and knowledge with process systems and equipment within the following areas: Bioreactors, Centrifuges, Chromatography skids and Columns, Prep and Hold tanks, CIP/SIP, Filling and Packaging equipment Uses expert knowledge about the processes, automation and process-specific technology to participate in troubleshooting as the Engineering technical lead.

Technical Analysis:

including process system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability. Project Management Lead/participate in

CAPEX/OPEX/CI

projects Own risk assessment for new systems and changes to existing systems Write/review project execution plans Lead/manage startup/commissioning activities (e.g. approve commissioning report, review/approve TOPs, create/update/review/approve SOPs...) Technical approvers of protocols and periodic monitoring Lead/manage project team including overseeing & providing guidance on contractors' activities Provides estimates of resource requirements Optimization & Compliance Own technical optimization of the field of care. Ensures that the facility equipment, machinery, documentation and technical support meet the compliance, quality and EHS standards. Leads/motivates activities to ensure a continuous optimization process. Leads/execute CAPA, deviation, change control, and risk assessment (quality, business and/or safety) Global Engineering Leads implementation and improvement of best practice of technical standards, procedures. Acts as a member of Global Engineering Biopharmaceuticals and of global Engineering Boehringer Ingelheim. Participates in peer-to-peer reviews as needed. Regulatory and/or

Organizational Requirements:

Regulatory requirement per GMP, OSHA and FDA Physical demands/surroundings

• work primarily in an office environment. Required to be on the process floor as necessary to perform work outlined in this profile. Some domestic and international travel may be required. Visual Demands
• must be able to read and see clearly with or without correction lenses. Attendance/schedule
• attendance requirements are based on general attendance policies and the needs of the business as set forth by direct manager.

Job Complexity:

Capable to balance conflicting priorities and agile to manage changing priorities Ability to establish highly functional relationships with diverse personalities Internal cross functional groups

• Mfg, SCM, Quality, CMO, Finance, IT External contingency worker, contractors, possible customers, auditor

Skills:

Knowledge of GMP compliance Technical expertise on process equipment/system Recognize safety requirements in manufacturing environment Equipment hands on experience Project leadership experience Minimum of 4 years' working experience in a GMP manufacturing environment Excellent oral and written communication skills Minimum 5 years and hands on experience with process system/equipment Capable to own and lead risk assessment, root cause investigation, project startup/commissioning/qualification. Expert on troubleshooting technical issues Owner of change control, deviation and CAPA Capable to lead projects (CAPEX or CI) Oversee contractor(s) and provide guidance/approval on activities at site

Education:

Bachelor's in Engineering, 5-10 years of related field experience or, Master's in Engineering, +5 years' of related field experience or P.E. License