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 Equipment Validation Engineers at Mid to Senior levels of experience to act as Consultants for our Mid-Atlantic Manufacturing Systems Compliance Division. Candidates with experience in biomanufacturing settings completing qualification (IQ/OQ/PQ), validation, and documentation projects will be given top priority. Applicants with a willingness to travel and/or commute to project sites are preferred.
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
- Conduct field inspections including piping and equipment walk-downs, operational startup and troubleshooting
- Track and report on progress to project deliverables, schedules, and budgets
- Develop risk assessment, system impact assessments, and validation plans
- Investigate deviations and write investigation reports
- Review, analyze and interpret system performance data for completed qualification and prepare a final package to summarize data
- Bachelor’s degree in life sciences, engineering or other related technical fields (or equivalent experience)
- Ability to communicate effectively at all levels in verbal and written form
- Capability to read and redline equipment P&ID and facility layout drawings
- Knowledge of validation lifecycle approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc.)
- Working knowledge of Quality by Design (QbD) principles and approach
- 1+ years in validation, quality systems, operations or engineering in pharmaceutical or other regulated industry
- Knowledge of how to draft Validation Project Plan
- Knowledge of how to draft & execute Cycle Development Protocols for Stopper Processor
- Knowledge of how to draft & execute Commissioning Protocols for Vial Filler, Vial Washer, Palletizer, Vial Labeler, Manual Conveyor, Tamper Evident, Overwrapper, and Case Packer/Palletizer
- Knowledge of how to draft & execute IOQ Protocol for Vial Filler and Vial Washer
- Knowledge of how to draft & execute PQ Protocols for Filler Scale Repeatability, Filler Stopper Detection, Vial Washer, Tunnel, Isolator, Smoke Study, Warming Chamber, Autoclave, Stopper Processor, Filling Line integrated, Pack Line Integrated
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.