Sequence Inc QC Technical Coordination Lead - EM and WFI Qualification in Framingham, Massachusetts
Sequence Inc. is a total quality solutions provider to the Pharmaceutical, Biotech, and other regulated and non-regulated 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 Validation, Quality & Compliance, Data Architecture & Analytics, Laboratory Informatics, Cold Chain & Facility Monitoring, Engineering, Integration & Automation, Construction Management, 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 seeking a QC Technical Coordination Lead - EM and WFI Qualification to report to our New England Laboratory Compliance Division. The QC Technical Coordination Lead will be responsible for all Environmental Qualification (EQ) and WFI coordination of facilities, utilities and equipment systems associated with GxP biopharmaceutical manufacturing sites. The Lead will generate, execute and close-out EQ test plans and/or qualification protocols required as part of change control, actively manage resources associated with test plan and/or protocol execution, investigate potential qualification alert levels and provide impact justification for CAPAs and deviations, and generate qualification-related reports and project plans associated with tech transfer and other site projects/initiatives. Only candidates with a willingness to travel and/or temporarily relocate will be considered.
Essential Functions and Responsibilities:
Generate, review, approve and execute departmental documentation (e.g., SOPs, data trends, validation project plans, protocols, test plans). Participate in document revisions, providing input, as necessary.
Oversee EQ Qualification for the site.
Assess change controls and perform validation impact assessments. Assign/manage resources to complete validation protocol execution activities.
Lead, manage and participate in the investigation of non-conformances per quality procedures, policies and regulations.
Collaborate with operations managers to effectively communicate project details and deliverables.
Cultivate positive relationships with clients.
Provide leadership on client projects, as needed.
Reporting and assisting with the complaint/issue process per Sequence procedures.
Support client projects as assigned.
Extensive knowledge of validation activities, including protocol generation, execution, and final report approval/closeout.
Strong understanding of industry standards for commissioning and validation of facilities, utilities and process equipment for cGMP manufacturing.
Strong experience with performing facility qualification, including environmental monitoring (EM) testing for process cleanrooms (ISO and EU classification).
Strong experience with performing utility qualification for the following systems: WFI, purified water, clean steam, process gasses, HVAC, vaporized hydrogen peroxide (VHP), CIP, Chilled Glycol, Wastes, etc.
Strong experience in equipment design, installation and start-up.
Subject matter expert for performing site change control validation impact assessments and supporting deviations associated with EQ.
Generate, execute and close-out EQ test plans and/or validation protocols required as part of change control.
Actively manage resources associated with the test plan and/or protocol execution.
Investigate EM execution alert levels and provide impact justification for CAPAs and deviations.
A proven track record of demonstrated leadership skills.
Ability to travel and or temporarily relocate to various client sites dependent upon project demands.
Bachelor’s Degree in Engineering, Biology, Mechanical Engineering or related Engineering discipline OR at least 4 years of experience in consulting or business development to pharmaceuticals, biotechnology, life science industry, or regulated industry.
Strong understanding of ISO 14644.
Effective client communication skills.
Strong interpersonal and relationship skills with a willingness to seek and develop open and honest relationships.
The ability to think creatively.
Strong technical writing skills.
The desire and aptitude to be successful in a fast-paced, dynamic environment.
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:
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
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 career 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.