Fill/Finish Qualification Consultant - Northeast
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 looking for a Fill/Finish Qualification Professional to join our Northeast Team on a full-time basis (salaried with benefits) for an opportunity within the Greater Boston Area. Candidates will need hands-on experience in the qualification (IQ/OQ/PQ) of fill/finish equipment, systems, utilities, and facilities. Direct experience in pharmaceutical/biotech industries is required. Applicants with a willingness to travel and/or commute to project sites are preferred.
Essential Functions and Responsibilities:
- Attending to clients as a full support solution to quality and compliance
- Daily management of project activities and deliverables
- Hands-on full-lifecycle qualification (IQ/OQ/PQ) of Fill/Finish equipment, including Interior & Exterior Vial Washers, Depyrogenation Tunnels, Isolators, (VHP), Fillers, Lyophilizers/CLUs (loaders/unloaders), Cappers, & Sterilizers/Autoclaves
- Providing Regulatory Guidance regarding compliance with intended specifications
- Validation documentation creation and development including GMP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
- Test Execution and Deviation Management
- Planning and scheduling of validation and Validation Lifecycle deliverables
- A bachelor’s degree from ABET accredited institution in engineering or related discipline, and/or at least three years’ experience IQ/OQ/PQ of fill/finish equipment, utilities, and facilities
- Qualification experience with biomanufacturing equipment (Fill/Finish), systems & facilities (FMS/BMS/Clean Rooms), and utilities (HVAC, WFI, OFA, Nitrogen)
- Excellent communication and organizational skills
- Ability to develop and manage client relationships while identifying new opportunities
- A willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks
- Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries
- Understanding of the client’s business and ability to offer impactful solutions fit their needs
- Understanding of business processes as applicable to manufacturing sciences
- Understanding of GxP, GAMP, CFR’s
- Understanding of how to apply SOPs, work instructions, and regulatory requirements
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
- A Three-Week Training Program
- 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.
We are unable to sponsor at this time.
- Pay Type Salary
- 1 Speen St, Framingham, MA 01701, USA