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Fill/Finish Qualification

1 Speen St, Framingham, MA 01701, USA Req #41
Wednesday, April 14, 2021
Thank you so much for your interest in Sequence!  We do our best to contact as many applicants as possible, but only those selected for an interview with our Talent Acquisition team will be contacted at this time.

We are currently interviewing candidates to join Sequence, Inc. as Fill/Finish Qualification Professionals within our Northeast Operations (Greater Boston Area) with majority of projects focused within the pharmaceutical/biotech realms. In this role, you will be responsible for the qualification (IQ/OQ/PQ) of fill/finish equipment, systems, utilities, and facilities. Direct experience in pharmaceutical/biotech industries is preferred.
 

This position is intended for those who embody Sequence’s core values of selfless Attitude, Aptitude for continued learning, and unstoppable Initiative. 
 

Do you love to travel and explore new places? This position may require travel for specific projects with the opportunity to grow and work locally, primarily within the Greater Boston Area. Most projects are within the pharmaceutical industry. If you are willing to travel out-of-state and/or temporarily relocate you will be given top priority for this role! 
 

In this role you will be held responsible for the day-to-day management of specific project deliverables, including, but not limited to: 

Position Accountabilities and Responsibilities: 

  • Attending to clients as a full support solution to quality and compliance
  • Daily management of project activities and deliverables
  • Full-cycle 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

At a Minimum, Your Skills Include:

  • At least three years’ experience in 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

It Would be Fantastic if You Also Had:

  • A bachelor’s degree from an ABET accredited institution in engineering or related discipline OR at least three years’ experience in IQ/OQ/PQ of fill/finish equipment, utilities, and facilities
  • Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries
  • 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

Here are Some of the Benefits We Offer: 
 

  • Competitive Pay as a Full Time Employee 
  • A Three-Week Training Program with on-going training thereafter 
  • Generous PTO/ Time off 
  • Bonus Plan 
  • Reimbursable Expenses (Phone, Internet, and Mileage to Client Site) 
  • 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 

About Us: 
 

Sequence Inc. is a total quality solutions provider to Pharmaceutical, Biotech, Life-Science 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 (full-lifecycle). We specialize in providing excellence in Engineering, CQV, and Quality & Compliance. 
 

Our employees embody core values that strengthen our culture and guide our overall success. The ability to maintain a selfless 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 value our employees, and beyond the great pay and benefits we offer, we care most about offering career opportunity and growth. 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 currently unable to sponsor. 

 

 

Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at 

Email: cburchell@sequenceqcs.com 
 

Equal Opportunity Employer, including disabled and veterans. 

 

If you want to view the EEO is the Law poster, please choose your language: English – Spanish – Arabic - Chinese 

 

If you want to view the EEO is the Law Supplement poster, please choose your language: English – Spanish – Chinese 

 

If you want to view the Pay Transparency Policy Statement, please click the link: English 

  

(21 CFR parts 11, 210, and 211), autoclaves, lyophilizers, washers, qualification, Gap analysis, CTU mapping, URS – User Requirement Specs, FRS – Functional Requirement Specs, SDD – System Design Description, VMP or MVP – Validation Master Plan, Traceability Matrix, Deviations, Commissioning, Facilities/Utilities, IQ/OQ/PQ – installation, operation, performance qualification, SOPs – Standard Operating Procedures, Execute/Execution, Requirements, Design, Testing, Documentation, Protocols, cGMP – current Good Manufacturing Practices, Lean Six Sigma, Yellow, Green, Black Belt, HVAC, Buffer, Washer, Lyophilizer, Fill/Finish, Mixer, CIP Skid, Bioreactor, Packaging, Serialization, Sterile/Sterilization/Aseptic, Clean Room, Elsai, Batch records 

Other details

  • Pay Type Salary
  • 1 Speen St, Framingham, MA 01701, USA