In support of site projects, technical transfers, and ongoing validation maintenance, this position will be primarily responsible for the design, authorship, and execution of qualification studies for the following major systems:
- Facilities, Equipment, and Utilities (FEU)
- Unit operations automation with Honeywell, Delta V, and PLC based systems
- Environmental monitoring
As required, this position will provide technical SME support to change controls, deviations, and CAPAs.
The scope of responsibility for this position includes commissioning and qualification, and maintenance of the validated state, of all direct impact manufacturing systems used to support the clinical development and commercialization of multiple therapeutic drug substance platforms.
Periodic travel may be required to local Shire operational sites outside of Lexington, MA.
Varies, 30% - 80%
Design, Author, execute, and summarize qualification activities in the following areas:
- Steaming / Autoclave
- Unit Ops Automation
- Validation Maintenance
Provide SME input to the following Quality System elements as a representative of the validation group:
- Quality Risk Management program
- Change Controls
- GMP Investigations
Provide SME input to the following site initiatives as a representative of the validation group:
- Technology transfers
- Site and multi-site level capital projects
- Site level Operational Excellence projects
- Site and multi-site level Quality System improvements with validation impact
Varies, 10% - 20%
Participate in partner audits and regulatory agency inspections as a representative of the validation group.
Participate in validation group training initiatives to support continuous improvement of validation best practices.
Proactively update validation programs guidances to reflect current regulations and trends.
Education and Experience Requirements
Bachelor's in Biology, Chemistry, Chemical Engineering or related field with a minimum of 8 years relevant experience or Master’s in related field with a minimum of 5 years relevant experience.
Key Skills, Abilities, and Competencies
Qualified candidates will demonstrate:
- Relevant work experience with the commissioning and qualification of biotechnology based manufacturing systems
- Proficiency with formal GMP investigations and root cause analysis
- Excellent written and verbal communication skills
- Ability to work independently in a fast paced environment and manage multiple projects and priorities
Complexity and Problem Solving
The successful candidate will:
- Exercise sound judgment, in cooperation with participating project stakeholders, to ensure that unexpected validation events are assessed and successfully resolved without impact to timeliness or quality standards.
- Analyze and evaluate validation related risk factors to studies and projects, and escalate issues with proposed solutions to senior management or leadership as necessary.
Internal and External Contacts
In support of ongoing validation responsibilities, the successful candidate will interact regularly with stakeholders from Quality Assurance, Quality Control, Site Engineering, Manufacturing, Facilties Engineering, and Operational Excellence.
Other Job Requirements
The ability to work at all MA site locations as required. The person in this role will be required to carry an iPhone and be on call as required to support process validation activities.
Location/Region: Lexington, MA