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Qualification and Validation Lead

Billerica, MA 01821

Posted: 01/16/2023 Employment Type: Direct Hire/Perm Job Category: QA/Automation Job Number: 536274 Is job remote?: No Country: United States

Job Description

Job Summary
Responsible for providing quality and technical support for commissioning, qualification and validation activities related to manufacturing equipment, processes, and utilities. Will support and facilitate the development and review of project plans, qualification protocols and reports for all stages of the qualification process, maintaining quality standards aligned with US FDA cGMP, QSR, ICH and other applicable international regulations and guidance documents.

Area Of Responsibility
  • QA oversight of commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories.
  • Qualification of various equipment, such as: utility equipment, lyophilizer, environmental monitoring system, labelers, liquid ampoule filler/powder auger, serialization systems and vacuum chambers.
  • Assessment of equipment/instrument related change controls to assure proper impact assessment to develop and maintain a qualified/validated state.
  • Review and assist in investigating deviations related to manufacturing, process, equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments.
  • Review equipment/instrument validation, qualification, requalification protocols including IQ, OQ, PQ.
  • Perform IT related activities including but not limited to production equipment and QC/ laboratory instrument.
  • Perform monthly facility walkthroughs and help drive the closure of any observations and assure compliance
  • Assist with internal and external audits.
  • Other duties as assigned.
Education and Job Qualification 
  • B.S. degree (preferably in Life Science/Engineering) required
  • Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment
  • Preferably knowledge of Trackwise (TW) to handle electronic Quality Manage System (eQMS) data, SAP, EDMS, LMS, Master Control etc.
  • Demonstrated excellent communication: verbal, written and presentation skills
  • Demonstrated ability to interact effectively with peers, management, and cross functional teams
  • Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines
  • Must be flexible in terms of working hours to meet requirements of position
  • Sound knowledge of pharmaceutical quality system requirements
  • Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project
  • Skills to independently evaluate situations and propose potential solutions are essential
  • A self-starter with a hands-on approach and a can-do attitude.
  • Ability to think strategically and to proactively identify issues in various aspects of the drug manufacturing process
Experience
  • Five to ten years of experience in the pharmaceutical, biopharmaceutical, medical device or related industry
  • Experience in the FDA regulated pharmaceutical or medical device industries
  • Experience performing inspections and investigations
  • Experience with EDMS, Trackwise, LMS preferred
Work Conditions:
  • Corporate Office Environment located in a Manufacturing/Production and Warehouse Facility
Physical Requirements:
  • Position requires the ability to sit and/or stand for a minimum of 8 hours per day; use hands and fingers to handle or feel, walk, bend, reach, lift, talk and hear
  • Close vision and ability to tell color differences/have normal color vision
  • Lift up to 35 lbs.
  • Must be able to wear safety glasses/goggles and other personal protection as required for entry and work in the manufacturing facilities
Travel Estimate:
  • Up to 5%
Target Salary Range: $100-120k. Salary will be commensurate with experience.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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