Sequence is a leader in providing quality and compliance services to the Pharmaceutical, Biotech, and Medical Device industries. United with our clients, we strive to provide services that result in products of the highest quality. Through our knowledge, experience, and integrity we offer a level of service that is unsurpassed industry wide. We Specialize in Providing Excellence in Automation & Control Systems Validation, Information Systems Validation, Software Configuration/Builds & Administration, Training, Equipment & Utility Validation, Laboratory Instrument Qualification, Project Leadership, Auditing, SOP Development, Remediation, and much more.

We are currently seeking a Project Engineer (Consultant level) for our Engineering Services division.  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:

o Author DCS Functional Requirement Specifications with input documentation such URSs, P&IDs, vendor specs, and sequence of operations
o Ability to develop/use Engineering tools to identify issues between Instrumentation (I/O) and DCS/PLC software prior to startup/shakedown
o Perform Receipt and Installation verification for control system hardware and various equipment supporting utilities and process operations
o Draft startup and shakedown documentation to assist process engineers with identification of mechanical, automation, and/or process issues prior to commissioning
o 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


o Facilitate cross-functional problem solving involving Engineering, Quality Operations, Regulatory Affairs, and Manufacturing 
o Ability to work independently and make decisions within defined areas of responsibility
o Develop project schedules based on automation constraints
o Ability to troubleshoot software issues and make the appropriate design documentation redlines
o Design reviews of P&IDs, FRSs, SDDs to ensure the desired functionality is achieved
o Evaluate and analyze commissioning and qualification data obtained through test execution to determine effectiveness and acceptability with regards to functionality and compliance (GMP)


o Perform P&ID walk-downs to determine As-Built drawings represent actual system and identify issues with instrumentation and/or equipment
o Identify discrepancies, conduct investigation to determine root cause, implements change, and drafts testing to demonstrate corrective action implementation reflects intended functionality
o Participate in meetings as the engineering representative for assigned projects involving project planning, scope development, design, construction, startup, qualification, validation and administration
o Interacts regularly with project team members and influences overall scope development and communicates with all levels of employees within and outside the team

 

Minimum Requirements:

  • BS or MS in a life science, engineering or equivalent work experience
  • Minimum of 5 years working within a GxP regulated setting (Laboratory, Quality, Manufacturing, IT) for the senior role, 2 years for the staff-level role
  • Familiarity with a variety of Laboratory Instrumentation/Equipment – Chemistry/Microbiology/Environmental Monitoring/Controlled Temperature Units
  • Troubleshooting various vendor instrument software applications
  • Exposure to lab operations and scientific processes associated with various area (Chemistry, Micro, Bio, EM etc.)
  • Ability to work independently and as a group on multiple projects at once
  • Work as a liaison between IT and Laboratory Departmental Management
  • Ability to adapt and work well with others, specifically Quality Assurance with review and approval of documentation
  • General knowledge of basic lab safety principles
  • Understanding of the Validation Life-Cycle (GAMP 5)
  • Understanding of business processes as applicable to the laboratory
  • Understanding of GxP, GAMP, CFR’s as they relate to the laboratory validation
  • Understanding of applying SOPs, work instructions and regulatory requirements to the Systems Validation

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 offer, 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 you 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.

 

Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at
Email: cburchell@sequenceqcs.com

Equal Opportunity Employer, including disabled and veterans.

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