Principal Engineer
TITLE: Principal Engineer
DEPARTMENT: Professional Service Operations
REPORTS TO: Associate Director Engineering
CLASSIFICATION: Exempt (salary)
STATUS: Full Time
LOCATION: Varies Between Remote, at a Client Site in the US
cGMPnow accelerates Next Generation Therapies to patients by providing GxP Manufacturing & QC Laboratory Equipment, GxP Computerized Systems, Commissioning & Qualification, and Procurement services
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 Principal Engineer will provide engineering support to develop and implement process concepts and designs on technically complex capital projects for FDA & EU regulated Advanced Therapeutic Medicinal Product (ATMP) industry. 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. The Principal Engineer is responsible for coordinating with internal and external resources including facilities, manufacturing, process development, architects, MEP engineers, and automation to ensure the design and project requirements are met. Project sizes will vary, and will consist of both new projects and continuous improvement efforts including both existing operations / retrofits and new construction.
COMPENSATION & BENEFITS:
Salary Compensation Range: $200,000 to $300,000 annual depending on years of relevant experience
This position is eligible for healthcare benefits with the employee 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, or Mechanical Engineering required
15+ years total experience in GMP-regulated industry
11+ years experience in process design & continuous improvement in Biopharmaceutical and/or Biotechnology industries
Knowledge of FDA, EMA, and other pharmaceutical regulatory standards and requirements
Knowledge and application of PIC/S, ISPE Baseline Guides, and ASME BPE
Knowledge and experience with manufacturing process and equipment 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 manufacturing support operations (ie. WFI, Cleanroom HVAC, QC laboratory equipment)
Knowledge of biosafety and containment strategies, and applying these in a Risk Assessment.
Ability to lead a project or area of a large project from a process perspective
Able to work in the US without sponsorship now or any time or in the future
ESSENTIAL FUNCTIONS and RESPONSIBILITIES:
Leads process data gathering and developing process requirements (i.e. Make a Batch, User Requirements Brief)
Leads efforts to perform the development of mass balances and constructing detailed equipment lists for complex ATMP manufacturing and laboratory equipment
Drives the development of process description narratives, process flow diagrams, process architecture, and P&IDs
Working directly with facilities, manufacturing, technical operations, and architecture 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 ATMP manufacturing and lab equipment
Writing testing requirements and attending factory acceptance tests (FATs) for 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
Oversees the work of Process Engineers
Traveling as required for client development and project execution
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
BlueBeam Studio and/or Revit proficient
OTHER:
Willingness to travel locally, within 60 miles of residence, for full time support at client site
Willingness to travel outside of local area, including internationally, 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. If you cannot do one of these physical requirements cGMPnow will make reasonable accommodations. Must be able to talk, write and understand the English language. Able to type/keyboard or enter data using a computer 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 protected 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).
Disclaimer:
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.
