M
USA - Engineer
Mindlance
- 🇺🇸 United States
- Hybrid
- 11 hours ago
- Change Management
- Risk Management
- GMP
11 hours ago
Location – Lexington, MA 02421
This is a Hybrid role with the expectation to be present on-site 3 days a week from Tuesday to Thusday.
Primary Duties
The individual will be expected to provide material qualification (MQ) support for Takeda Massachusetts Biologics Operations (MA Bio Ops) site located in Lexington and Cambridge MA, USA. The MQ activities related to the Lexington & Cambridge manufacturing site include, but are not limited to, the following areas:
• Development of MQ protocols, reports and other documentation for single use components and QC released raw materials within all manufacturing processes.
• Developing MQ validation packages including acquisition of necessary data and summation into final reports.
• Supporting the Human Daily Exposure (HDE) program including technical assessments and Extractables/Leachables (E/L) caclulations to ensure patient safety related to commercial Drug Substance (DS) Manufactured at MA Bio Ops
• Providing MQ related technical, compliance and quality support to the TAK-921 Tech transfer team as required.
• Assisting technical assessments on change controls, deviations and investigations, assessing proposed changes to validated process components to identify requirements necessary to maintain validated status.
• Represent MQ in meetings and participating in operations, engineering, quality, MSAT and new prodict introduction related strategy discussions as required.
• Interface with other site functions including procurement, quality, manufacturing, engineering, compliance and process development to effectively communicate requirements for material qualification and ensure they are a part of routine site business processes.
Job Function and Description
(75% of the time)
Write, execute, analyze results and summarize MQ activities in the following areas:
• Tech transfer (new product introduction)
• Change management
• Continuous lifecycle management
Develop and assess the following Quality System elements for material qulaification:
• Quality Risk Management program
• CAPAs
• Change Controls
• Deviations
• GMP Investigations
• Vendor Change Notifications
Champion site projects involving QC released chemicals and single use raw materials:
• Lead development of technical strategy/philosophy for MQ activities
• Represent MQ during tech transfer activities as required.
• Represent MQ during site GMP activities and participate on cross-functional teams
• Own MQ Quality Systems, as required, and manage project through to closure per timelines
(20 % of the time)
Identify and deploy opportunities for continuous improvements and adoption of best practices. Represent MA Bio Ops MQ in the global MQ community of practice.
(5% of the time)
Participate in regulatory agency inspections for MQ.
Education and Experience Requirements
Essential:
Bachelor's in Material Science, Mechanical, Biomedical or Chemical Engineering or related science or engineering field with a minimum of 4 years relevant experience
or Master’s in related field with a minimum of 2 years relevant experience.
Desired:
Prior experience working in the pharmaceutical or biotech industry, with mAb manufacturing (upstream or downstream) knowledge.
Knowledge of single use manufacturing equipment design, and Single use and chemical specification and qualificaction.
Familiarity with major suppliers of materials, standards for material selection and methods for testing the quality attributes as well as leachable and extractables.
Soft Skill and Project Management Requirements
The candidate:
• Will exercise judgment within defined procedures/practices to determine appropriate action.
• Must have the ability to analyze data, quantify risks, and identify gaps independently.
• Must have the ability to propose solutions to problems and escalate issues with proposed solutions to management as necessary.
The person in this role will be instrumental in working with other members of the Quality Assurance, Quality Control, Supplier Quality, Supply Chain, Manufacturing and Engineering organizations to develop and execute MQ studies and projects to enhance the manufacturing systems and processes to compliantly and efficiently achieve organizational goals.
Other departments this person will work closely with include: Process Development, Process Validation, Regulatory Affairs, and Facilities.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
USA - Engineer · Mindlance