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 multiple Laboratory Instrument Validation Specialists (Senior Consultant level) for our Validation and Compliance Division. Persons will be responsible for the day-to-day management of their specific project activities and deliverables, including, but not limited to:
- Serving as validation representative for laboratory instruments and partnering with the laboratories, Quality System Administrators, Business Technology, Instrumentation and Quality Engineering on implementing new instruments at the site.
- Initiates and leads risk assessment, gap analysis, and deviation management for commissioning of, changes to or decommissioning of laboratory instruments and associated instrument control software where applicable within the Quality Control laboratories.
- Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs.
- Ensures lab instrument’s adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines. Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence. For systems found unable to fully comply, formulate workarounds/strategies with core stakeholders to mitigate the gaps.
- Assists the system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and setting up preventive maintenance plans.
- Completes periodic reviews of laboratory instruments and associated instrument control software with a focus on change control, deviation investigations and CAPA to ensure compliance and validated state of the instrument. Previous experience with Trackwise PR/CAPA systems preferred.
- Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.
- May supervise and/or mentor junior level engineers.
- All other duties as assigned.
Essential Functions and Responsibilities:
- 5-7 years of experience in the validation of laboratory instruments including those with computerized systems attached in a biotechnology or pharmaceutical cGMP manufacturing environment.
- Hands on experience operating/validating various laboratory instrument systems (e.g. AA, FT-IR, IC, ICP-MS, TOC, UV_Vis).
- Demonstrated expertise in identifying as well as formulating procedural controls to compensate for shortcomings in the system’s data integrity and FDA 21 CFR Part 11 controls.
- Bachelor’s degree in a science or engineering related discipline with knowledge of quality operations laboratory processes.
- 3-5 years of experience in performing periodic review of laboratory instruments including those with computerized systems.
- Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements.
- Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
- Ability to manage multiple activities and constantly change priorities.
- Exposure to lab operations and scientific processes associated as well as familiarity with a variety of laboratory instruments with various areas (Chemistry, Micro, Biological, EM etc.)
- Strong critical thinking and problem-solving skills.
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 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.