Project Engineer - Northeast
Sequence Inc. is a total quality solutions provider to Pharmaceutical, Biotech, Life-Science industries. United with our clients, we strive to provide services that result in deliverables of the highest quality. Through our knowledge, experience, and integrity we offer a level of service that is unsurpassed industry-wide (full-lifecycle). We specialize in providing excellence in Validation, Quality and Compliance, Data Architecture & Analytics, Laboratory Informatics, Cold Chain & Facility Monitoring, Engineering, Integration & Automation, and Construction Management.
At Sequence Inc., our employees embody core values that strengthen our culture and guide our overall success. The ability to maintain a selfless attitude creates a respectful environment where ideas are shared and valued. Our teams possess the technical proficiency to do the work and the Aptitude to continue learning, growing and stretching their potential. Our unstoppable Initiative and willingness to get things done using new ideas grows our capabilities and drives our future achievements.
We are currently considering Project Engineers at various levels of experience on a full-time only basis to act as hands-on Consultants for our Northeast Engineering and Technical Services Division to be responsible for projects in automation and controls, commissioning, and process engineering in biomanufacturing, biotech, and other regulated industries (21 CFR parts 11, 210, and 211). The majority of projects are within the pharmaceutical industry, with potential for medical devices, general manufacturing, and agriculture. Candidates with the ability to travel out-of-state and/or temporarily relocate will be given top priority for this role. Persons will be responsible for the day-to-day management of their specific project activities and deliverables, including, but not limited to:
- Develop project schedules
- Design reviews of P&IDs, FRSs, DDSs to ensure the desired functionality is achieved
- Evaluate and analyze commissioning and qualification data obtained through test execution to determine effectiveness and acceptability with regards to functionality and compliance (GMP)
- Perform P&ID walk-downs to determine As-Built drawings represent the actual system and identify issues with instrumentation and/or equipment
- Identify discrepancies, conduct investigations to determine root cause, implement change, and draft testing to demonstrate corrective action implementation reflects intended functionality
- Participate in meetings as the engineering representative for assigned projects involving project planning, scope development, design, construction, startup, qualification, validation, and administration
- Perform Receipt and Installation verification for control system hardware and various equipment supporting utilities and process operations
- Draft startup and shakedown documentation to assist process engineers with identification of mechanical, automation, and/or process issues prior to commissioning
- Draft commissioning and qualification protocols to sufficiently demonstrate the process is designed and fit for the intended use
- A bachelor’s degree from ABET accredited institution in engineering or related discipline, with experience in the design and/or commissioning of industrial control systems, utilities, and/or process equipment.
- Basic understanding of automation platforms including PLCs, Distributed Control Systems, Building Automation Systems, and other automation platforms
- Must have a proficient understanding of life cycle documentation: User Requirement Specification (URS), Functional Requirement Specification (FRS), and Detailed Design Specification (DDS)
- Strong technical writing skills and proficient utilization of MS Word, Excel, Visio, PowerPoint, and Project
- Technical background encompassing process and automation with the ability to identify issues with regard to process and/or automation
- Project Engineer I: 1-3 years of applicable work experience in the pharmaceutical, biotechnology, or other regulated industry
- Project Engineer II: 4-7 years of applicable work experience in the pharmaceutical, biotechnology, or other regulated industry
- Senior Project Engineer: 8+ years of applicable work experience in the pharmaceutical, biotechnology, or other regulated industry
- Principal Project Engineer: 10+ years of applicable work experience in the pharmaceutical, biotechnology, or other regulated industry
- Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries
- Understanding of the client’s business and ability to offer impactful solutions to fit their needs
- Understanding of business processes as applicable to manufacturing sciences
- Understanding of GxP, GAMP, CFR’s
- Understanding of how to apply SOPs, work instructions, and regulatory requirements
- Ability to troubleshoot software issues and make the appropriate design documentation redlines
- Ability to develop/use Engineering tools to identify issues between Instrumentation (I/O) and DCS/PLC software prior to startup/shakedown
- Author DCS Functional Requirement Specifications with input documentation such as URSs, P&IDs, vendor specs, and sequence of operations.
- Competitive Pay
- A three-week training program
- Medical, Dental, and Vision Insurance
- Employer-paid long-term disability and short-term disability
- Employer-paid maternity and paternity leave
- A $50,000 team member only life insurance & ADD policy
- A fully vested 401k plan with employer contributions
- Generous PTO/ Time off
- Bonus Plan
- Reimbursable Expenses (Phone, Internet, and Mileage to Client Site)
We value our employees, and beyond the great pay and benefits we offer, we care most about offering career opportunity. We are a rapidly growing consulting firm and would love to discuss the prospect of you joining our team. Sequence Inc. is proud to provide Equal Employment Opportunities, EOE/M/F/D/V, to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Candidates who are currently employed by a client of Sequence or an affiliated Sequence business may not be eligible for consideration.
We are unable to sponsor at this time.
- Pay Type Salary
- 1 Speen St, Framingham, MA 01701, USA