TITLE: Engineer V

DEPARTMENT: Professional Service Operations

REPORTS TO: Associate Director Engineering

CLASSIFICATION: Exempt (salary)

STATUS: Full Time

LOCATION: Varies Between Remote or at a Client Site in the San Diego, CA area

cGMPnow accelerates Next Generation Therapies to patients by providing GxP Manufacturing & QC Laboratory Equipment, GxP Computerized Systems, Commissioning & Qualification, and Procurement services using project-dedicated expert resources.

With our unique project delivery methodology and owner-focused involvement, we bring new products to the market faster by providing cGMP systems faster.

POSITION SUMMARY:

The Engineer will provide process, equipment and project engineering and, at times, project management and business development functions. Overall this role will lead and support development and implementation process concepts and designs on technically complex capital projects for the FDA & EU regulated Advanced Therapeutic industries. This person must be an energetic, self-motivated, organized and innovative individual who shall possess the skills required to successfully support and execute project tasks and deliverables, be a collaborative team player, and have a strong drive to deliver results. This role covers engineering for complex cGMP manufacturing and lab facilities. This engineer may lead projects, ensuring timely and budget-conscious completion through planning, resource management, budget oversight, progress monitoring, and stakeholder communication. The engineer may also assist with proposal development, business development, and strategic planning, including opportunity identification, proposal preparation, client engagement, and project evaluation.

COMPENSATION & BENEFITS:

Salary Compensation Range: $145,000 - $175,000 annual

Potential Commission Compensation Range: $0-$50,000+ annual

This position is eligible for healthcare benefits with the employee base premiums 100% paid for by the company, enrollment in a retirement savings plan with company contributions, company matching of charitable contributions, profit sharing and is eligible for paid time off. Training, conferences and professional registration dues are eligible for reimbursement.

Please note that the salary information is a general guideline only. Other factors such as (but not limited to) scope and responsibilities of the position, candidate's work experience, education/ training, key skills as well as market and business considerations when extending an offer.

QUALIFICATIONS

Must have excellent planning skills, be highly organized and detail oriented, able to support multiple projects simultaneously and able to adapt to changing environments and priorities. Must be a self-starter with the ability to work productively and meet benchmarks and goals in a timely fashion. Strong interpersonal communication and organizational skills are required.

REQUIREMENTS:

• 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 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 cGMP products (i.e.fermentors, bioreactors, mixers, pumps, chromatography, TFF, spray dryers, isolators, and vial/bag fillers)
• Knowledge and experience with (i.e. Process Gas Systems, WFI, Clean Steam Generators, Autoclaves, CIP Skids, Cleanroom HVAC, and QC laboratory equipment)
• Knowledge of , 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
• Ability 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

ESSENTIAL FUNCTIONS and RESPONSIBILITIES:

Engineering

• 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

Project Engineering

• 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
• Proficiently and steadfastly helping to manage project changes (scope, schedule, budget)
• 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 assess cost and schedule impacts resulting from Client scope changes
• Monitors project budgets and schedules for trends/compliance to budget and prepare periodic reports and presentations
• Support 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
• Support management of RFPs and approval of submittals
• Oversees the work of Engineers
• Conduct and support project meetings with user groups and project stakeholders

Business Development

• 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 maintain 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

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
• All other duties as assigned

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.

cGMPnow is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: cGMPnow is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, family or parental status, or any other status of a protected class by the laws or regulations in the locations where we operate. cGMPnow will not tolerate discrimination or harassment based on any of these characteristics.

The term “protected class” refers to groups of people who are legally protected from being harmed or harassed by laws, practices, and policies that discriminate against them due to a shared characteristic (e.g. race, gender, age, disability, or sexual orientation).

The preceding job description has been designed to indicate the general nature and level of work performed by the employee(s) within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees in this position. Job descriptions are not intended as and do not create employment contacts. The organization maintains its status as an at-will employer.

Pay: $145,000.00 - $175,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: Hybrid remote in San Diego County, CA