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.

Sequence Inc. is currently seeking a Senior Laboratory Validation Engineer with experience in Quality Control Laboratory environments for our New England Laboratory Compliance Division. Candidates with experience in 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.   This is a full-time employment opportunity (salaried with benefits). 

Essential Functions and Responsibilities:

• 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.

• Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.

Preferred Experience:

• 8+ 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, HPLCs).

• 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.

• Project Management experience with mid to complex level validation projects.

Minimum Requirements:

• Bachelor’s degree in a science or engineering related discipline with knowledge of quality operations laboratory processes.

• 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.

• 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
• 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.