Sequence Inc. is a total quality solutions provider to the Pharmaceutical, Biotech, and Medical Device 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. We specialize in providing excellence in Automation & Control Systems Validation, Information Systems Validation, Software Configuration/Builds & Administration, Training, Equipment & Utility Qualification and Validation, Laboratory Instrument Qualification, Project Leadership, Auditing, SOP Development, Remediation, and much more.
At Sequence Inc., our employees embody core values that strengthen our culture and guide our overall success. The ability to maintain a selfless, humble 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 Mid to Senior levels of experience to act as Consultants for our Mid-Atlantic Engineering and Technical Services Division to be responsible for projects in automation, commissioning, and process development in biomanufacturing, and biotech industries. 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 will be given preference 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:
Essential Functions and Responsibilities:
- Create and execute commissioning and qualification protocols/test plans for facilities, utilities and equipment using a risk-based approach
- Create equipment and process specification documentation
- Author DCS Functional Requirement Specifications with input documentation such as URSs, P&IDs, vendor specs, and sequence of operations
- 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 the 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
- Evaluate and analyze commissioning and qualification data obtained through test execution to determine effectiveness and acceptability with regards to functionality and compliance (GMP)
- 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
- A bachelor’s degree from ABET credited institution in engineering or related discipline, together with at least three years’ experience in the design and commissioning of industrial control systems in a manufacturing environment
- 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.
- Knowledge of validation lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, 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 Equipment Validation (IOV protocols generation, execution, closure)
- Knowledge of PQ protocols for AWFI water system (PQ protocol generation, execution closure)
- Knowledge of Mixing study for new vessel
- Knowledge of Engineering run for new vessel
- Knowledge of PQ for new vessel
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
- Employer-paid long-term disability and short-term disability
- A $50,000 team member only life insurance & ADD policy
- 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 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.