Engineer V in San Diego

About the role

The Engineer V plays a critical role in the development and implementation of process concepts and designs for technically complex capital projects in the FDA and EU regulated Advanced Therapeutic industries. This role involves leading and supporting the development and implementation of process concepts and designs, project management, and business development functions.

Responsibilities

• Gathering process data and developing project requirements
• Performing the development of mass balances and constructing detailed equipment lists for complex cGMP manufacturing and laboratory equipment
• Developing process description narratives, process flow diagrams (PFDs), and P&IDs
• Generating User Requirement Specification documents
• Working directly with facilities, manufacturing, technical operations, and facility planners to layout the process needs including equipment, space, adjacencies, and flows
• Working with the PM and other discipline leads to ensure process deliverables and all the necessary details related to the process are delivered on time, fully coordinated, and within the project budget
• Researching process equipment providers and making recommendations/selections based on project requirements
• Writing process equipment specifications for complex cGMP manufacturing and lab equipment
• Writing testing requirements and attending factory acceptance tests (FATs) for equipment
• Performing receipt verification of manufacturing, lab and process utility equipment
• Specifying and coordinating installation, startup and commissioning services by vendors or 3rd parties for manufacturing, lab and process utility equipment
• Writing and updating SOPs as required for new process and project implementations
• Supporting projects after construction documents are issued, reviewing submittals, answering RFIs, and field verifying progression of process scope is proceeding per the intent of the design
• Supporting activities of CAD and Designer support staff
• Staying abreast of the latest technologies used in our industry and being aware of the approximate costs of the various technologies that could be used to solve our clients' design challenges
• Assisting the project manager with overall project deliverables in accordance with the PEP, budget, schedule, and the cGMPnow Quality Plan
• Supporting the PM for successful execution of projects using client procedures and industry best practices to the agreed upon scope, schedule, budget and technical quality
• Proactively identifying project risk and managing / mitigating risk
• Supporting internal and external project team meetings and generating and reporting progress against deliverables
• Supporting weekly and day-to-day activities of project technical staff and administrative staff such as training assignment management, meeting minutes, decision logs, updating organizational charts, supporting information cascades
• Helping manage client relationships and being responsible for client satisfaction
• Quickly assessing cost and schedule impacts resulting from Client scope changes
• Maintaining project budgets and schedules for trends/compliance to budget and preparing periodic reports and presentations
• Supporting oversight, coordination and execution of capital and maintenance projects from inception to turnover to user groups, including project scoping, preliminary and detailed design and review, CAPEX document development and approval, construction/installation, commissioning, startup and qualification
• Assisting with coordination of all technical activities on assigned projects. Responsible for having an awareness of and ability to recognize technical problems
• Supporting management of RFPs and approval of submittals
• Oversees the work of Engineers
• Conduct and support project meetings with user groups and project stakeholders
• Supporting the generation of draft proposals in response to client RFPs for PM review. Examples include but not limited to Project Execution Plans (PEPs), Staffing Plan, Schedule, Cost Estimate and Earned Value Tracking Tools
• Sharing with project PM potential opportunities observed for marketing services to clients and consistently maintaining client contact
• Support preparation of detailed project cost estimates and schedules
• Author proposals for small to medium sized projects (<$1M)
• Lead team efforts to develop large proposals ($1M+)
• Verify proposal alignment to cGMPnow Business Plan and brand
• Document status of proposals in the proprietary cGMPnow RFP Log system

Qualifications

• B.S. Degree in Chemical, Biological, Biopharmaceutical or similar engineering degree required
• 6+ years total experience in GMP-regulated industry
• 4+ years experience in process design and engineering project management (or PM support capacity) in Pharmaceutical, Biopharmaceutical and/or Biotechnology industries
• Experience and working knowledge of cGMP compliance
• Knowledge of FDA, EMA, and other pharmaceutical regulatory standards and requirements
• Knowledge and application of PIC/S, ISPE Baseline & Good Practice Guides and ASME BPE
• Knowledge and experience with manufacturing process for Advanced Therapeutics Medicinal Products (ATMPs), such as autologous & allogeneic cell therapy, gene therapy, viral vector, stem cells, mRNA, and plasmid modalities
• Knowledge and experience with equipment for manufacturing cGMP products (i.e. fermentors, bioreactors, mixers, pumps, chromatography, TFF, spray dryers, isolators, and vial/bag fillers)
• Knowledge and experience with cGMP process utility and support operations (i.e. Process Gas Systems, WFI, Clean Steam Generators, Autoclaves, CIP Skids, Cleanroom HVAC, and QC laboratory equipment)
• Knowledge of biosafety and containment control strategies, and applying these in a Risk Assessment
• Ability to lead a small project entirely or area of a large project from an engineering perspective
• Excellent verbal, written and presentation skills
• Able to communicate and work with staff at all levels
• Able to work in the US without sponsorship now or any time or in the future

Skills & Abilities

• Strong candidate will possess the following key attributes:
• Team player, hands-on attitude, willingness to be actively involved
• Hard working, driven, results-oriented and focused on success
• High ethical standards and integrity
• Ability to perform work with little to no direction
• Effective oral and written communication
• Personal computer and keyboarding
• Customer service including attentive and active listening with management, employees, vendors and customers
• Critical thinking and problem solving
• Time management, organizational and planning processes
• Manage multiple priorities and multi-task with frequent interruptions
• Flexible in times of change and adapt to changing environments and priorities
• Take initiative and plan ahead
• Maintain a good attitude while working under pressure and defuse stressful situations
• Work in a team environment and work effectively with other departments to accomplish goals
• Work independently with little or no supervision
• Plan, conduct and attend meetings in person or via teleconference software

Knowledge

• Operating standard office equipment including; personal computers, peripherals, and typical office equipment (telephone, copier, printers, scanners, etc.)
• Microsoft Office Suite (Word, Outlook, PowerPoint, Excel) and other related software programs
• Google Suite proficient (including Google Docs, Google Sheets, Google Slides)
• BlueBeam Studio and/or Revit proficient

Other

• Experience in consulting firms preferred
• Must be comfortable working remotely
• Willingness to travel locally, within 60 miles of residence, for full time support at client site
• Willingness to travel outside of local area up to 25% of the time over a calendar year

Physical Requirements

• The position requires intermittent physical activity of sitting, standing, walking, bending, stooping, crouching and lifting up to 25 pounds on occasion.
• Must be able to talk, hear, stand, sit and type/keyboard or enter data by using a computer and monitor for up to 8 hours per day.
• Must possess normal manual dexterity and eye-hand coordination.