Formed in 2002 out of a need for high-caliber consultants within the life sciences industry, Sequence, Inc. is well-known in regulated industries as a commissioning, validation and engineering services provider, specializing in quality and compliance services for software, IT infrastructure, laboratory instruments, analytical methods, equipment, automation, processes, cleaning and utilities, as well as process optimization, laboratory software support, remediation, regulatory compliance services, system/facility startup and much more. All of our work is done in-house with oversight from a management team that cuts its teeth in regulatory compliance.
We are currently seeking a Project Engineer (Consultant level) in the Greater Boston Area to be responsible for projects in automation, commissioning, and process development in the biomanufacturing and biotech industries. The majority of these projects are within pharmaceuticals, with potential for medical device, general manufacturing, and agriculture.
Candidates with the ability to travel out-of-state will be given preference on this role. Persons will be responsible for day-to-day management of their specific project activities and deliverables, including, but not limited to:
Essential Functions and Responsibilities:
- Author DCS Functional Requirement Specifications with input documentation such as URSs, P&IDs, vendor specs, and sequence of operations.
- Ability to develop/use Engineering tools to identify issues between Instrumentation (I/O) and DCS/PLC software prior to startup/shakedown.
- 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 control system commissioning and qualification protocols to sufficiently test control system hardware and software to demonstrate the process is designed and fit for intended use.
- Facilitate cross-functional problem solving involving Engineering, Quality Operations, Regulatory Affairs, and Manufacturing.
- Ability to work independently and make decisions within defined areas of responsibility.
- Develop project schedules based on automation constraints
- Ability to troubleshoot software issues and make the appropriate design documentation redlines.
- Design reviews of P&IDs, FRSs, SDDs 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.
- Interacts regularly with project team members and influences overall scope development and communicates with all levels of employees within and outside the team
- Basic understanding of automation platforms including PLCs, Distributed Control Systems, Building Automation Systems, and other automation platforms.
- Basic understanding of common life science processes such as Buffer Systems, CIP Skids, Chromatography, Ultra-filtration/Diafiltration (UFDF), WFI Storage & Distribution, RO Storage & Distribution, HVAC, etc.
- Must have a proficient understanding of life cycle documentation: User Requirement Specification (URS), Functional Requirement Specification (FRS), and System Design Description (SDD)
- Knowledge of ASTM-2500 and risk-based testing methods with regard to control system commissioning and qualification
- Strong technical writing skills and proficient utilization of MS Word, Excel, Visio, Powerpoint, and Project
- General understanding of project scheduling
- Technical background encompassing process and automation with the ability to identify issues with regard to process and/or automation.
- ABET-accredited B.S. in an Engineering Discipline (Chemical, Mechanical, Electrical, etc.)
Our consultants must be knowledgeable and willing to go the extra mile in service of a client, your success is our success. Here are some of the Benefits we offer:
- Competitive Pay
- Medical, Dental, and Vision Insurance
- 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 care most about offering 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 be an Equal Opportunity Employer, M/V/D/F. You will be considered for this position based upon your experience, without regard to race, color, religion, sex, national origin, age, sexual orientation, ancestry; marital, disabled or veteran status. Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Sequence.
Candidates who are currently employed by a client of Sequence or an affiliated Sequence business may not be eligible for consideration.