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Associate Project Engineer (2719-2722AE)

Verista

This is a Full-time position in emeryville, CA posted January 3, 2023.

Description

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Requirements

Field Engineer Responsibilities:

This position requires advanced learning; technical precision; and consistent use of independent judgment and discretion. Project Engineers/Managers conduct project management activities for Pharmaceutical and Medical Device process manufacturing, laboratory, IT, and packaging equipment projects. Managing internal and external Verista customer purchase orders for capital projects to ensure all aspects of services and capital project execution are delivered consistently and efficiently; always meeting project timeline, budget, quality, safety, standards, internal expectations, and client expectations. Verista Project Engineers/Managers are highly technical and knowledgeable within the technical area of expertise; have excellent project management and communication skills; and possess high technical aptitude to deliver complex solutions to our customer base. These jobs are responsible for schedule management, budget control, vendor/contractor management, determining return on investment (ROI) justification, team morale, change control, and validation.

Specific Responsibilities:

  • Proactively assisting and/or developing, implementing, and clearly communicating project scope, schedules, and budgets to ensure that project milestones are met throughout the project in accordance with the client contract and internal scope of work documentation, while maintaining a positive team atmosphere.
  • Managing internal project scope of work, budget, timeline, and change orders.
  • Taking responsibility for materials planning, budget development and cost control for assigned projects.
  • Specifying and procuring equipment needed on the project(s).
  • Managing and performing the start-up, commissioning, and validation of manufacturing, laboratory, IT and packaging equipment and associated support systems (such as utilities).
  • Leading the CQV (Commissioning, Qualification and Verification) processes for protocol development and execution.
  • Leading internal and/or client management activities for assigned projects: o Identifying and addressing complex technical issues and resourcing.
    • Supporting team members; acting as the liaison to the client for discussing changes in scope of work, timeline, or budget.
  • Providing frequent/clear/concise project updates to internal/external customers (bi-monthly minimum).
  • Utilizing troubleshooting/problem solving skills to drive solutions to equipment/process issues, including FMEA and root cause analysis methodology.
  • Providing technical expertise on equipment/processes/facilities/utilities in manufacturing, laboratory, and packaging areas.
  • Leading the team to complete equipment design and specification, vendor bids, vendor selection, and equipment purchasing.
  • Interfacing with vendors to ensure vendors will deliver parts, materials, components and equipment on-time, on-budget and to technical specifications.
  • Managing the process and budget for samples of packaging materials or other necessary samples as part of the selection and procurement process and overall project execution.
  • Developing and creating technical validation and engineering.
  • Developing relocation and installation plans including Rigging, Electrical and Piping.
  • Developing, writing, and executing engineering studies.
  • Developing SOPs/Guidance Documents for project equipment and processes which are highly complex and require advanced engineering to develop.
  • Performing Quality investigations (CAPA, Event, Periodic Reviews).
  • Maintaining, updating, and communicating project status via dashboards or other customer preferred method.
  • Executing projects to internal or customer standards, while also making recommendations to update standards to meet best practices

You will have:

  • This position requires a minimum of a Bachelor’s degree in an Engineering or Scientific degree
  • Capital project management in fast-paced, highly regulated industries
  • CQV Validation and Engineering experience
  • Industrial/Manufacturing engineering experience involving compliance, procedures, and process improvements in highly regulated industry involving GMP, FDA, OSHA, and Change Control
  • Experience with facility processes including mechanical systems such as HVAC, refrigeration, utility systems (purified water, compressed air), process control automation
  • Troubleshooting experience with automated equipment (PLCs, HMIs, PC based controls), laboratory systems, and/or enterprise software systems
  • Proficiency in understanding electrical, mechanical, piping, instrumentation (P&ID), and facility drawings
  • Experience with FMEA and other risk assessment tools

Desired Skills:

  • Experience in maintaining Lab Operations systems (inventory management. restocking, and shipping to/from development laboratories)
  • Experience in maintaining supplies, and equipment inventory, as well as purchasing.
  • Experience setting up new lab areas
  • Project management with proven ability to create achievable project plans using state-of-the art project management tools. Microsoft Project at a minimum
  • Strong English communication skills (written and verbal)
  • Intermediate proficiency with Word, Excel, MS Project, PowerPoint o Word (work with large documents containing tables, TOC, styles, track changes)
    • Excel (create, modify charts, filter data, use of functions within multiple worksheets)
    • MS Project (schedule creation, milestone tracking and management, and assignment of resources)
    • PowerPoint (customize templates, make presentation interactive, professional layout)
  • Direct experience authoring/editing/executing validation documents for equipment/computer systems/facilities/utilities including FAT, IQ, OQ, PQ and change controls
  • Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:
    • Good Documentation Practice (GDP) in pharmaceutical environment
    • ASTM-E2500
    • ISO 14971 – risk management for medical devices
    • ISPE Applied Risk Management for C&Q
    • ISPE Science and Risk Based Approach for the delivery of facilities, systems, and equipment
    • ICH 8, 9, 10 – Knowledge of Risk management and Risk Analysis Tools
  • Strong capabilities in applying FDA regulations
  • Strong problem-solving abilities with demonstrated understanding of Good Engineering Principles
  • Budget planning and budget management
  • Capacity to make independent sound decisions and independently manage priorities
  • Proven attention to detail and organization (including technical proofreading, follow-through, and project communication)
  • Experience with and tolerance for high levels of challenge and change
  • Experience and capability of effectively communicating goals, timelines, and issues (written and orally) with rationale to different levels within internal and external organizations

Benefits

Why Verista?

  • High growth potential and fast paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company paid medical premiums for Employee option.
  • Company paid Life, Short-Term, and Long-Term Disability insurances
  • Dental & Vision insurances
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • Leadership development training, career planning, and tuition reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Maternity, Parental Leave and Bereavement

Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing, and distribution. This experience brings together decades of knowledge, the most advanced engagement platforms, as well as transformative technologies. This allows clients to benefit from the ease, efficiency, and trust that results from working with one partner who excels across specialties.

For more information about our company, please visit us at Verista.com or follow us on LinkedIn.

  • Verista is an equal-opportunity employer.