Model Risk Analyst III - Validation
M&T Bank$82,783 - $137,972/year
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, Gene Therapy, CDMOIndustries
Requirements
- Bachelor's degree in Engineering or related field – required. Master’s degree or PhD – desired
- B.S. with 8+ years’ experience, or Master’s degree with 6+ years’ experience
- Preferred experience working in 2 or more functional areas
- Experience with biologic drug manufacturing
- Understanding of general cGMP standards and practices
- Working understanding of process equipment and unit operations (Bioreactors, Chromatography, TFF, Autoclaves, media/buffer preparation, etc.) and associated process utility systems
- Able to lift 40 lbs. without assistance
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Comfortable supporting concurrent issues and working in an exciting and fast-paced environment
- High ethical standards to support a professional business code of conduct
Responsibilities
- Ensure all equipment and system design documentation is organized and meets cGMP regulatory standards
- Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or interpersonal metrics
- Establish and detail the Plainville platform for client processes, enabling rapid tech transfers from clients to the site, while owning equipment readiness for all customer programs, including the generation of utilization heat maps and critical risk registers for all assets on site
- Organize and lead ad hoc multi-functional teams to run investigations and implementation of changes
- Drive continuous improvement and operational excellence through correcting processes and systems and instilling strong ownership and accountability
- Ensure high levels of communication with team; Proactively identify and raise key risks and issues to system owners
- Drive technical leadership, program management and clients to implement product / process improvements; participates and/or may lead multi-functional projects
- Acts as Engineering authority for assessments for change controls, validation protocols, and document changes
- Generate, review and approve departmental documentation (e.g., SOPs, protocols, final reports, data trends)
- Plan, schedule, and resource with team members for validation project initiatives, including protocol generation, execution and closeout
- Drive validation activities during the tech transfer of new products in the manufacturing facility, including the development of validation plans
- Develop and maintain Requalification program for the site
- Support client and regulatory audits
- Establish and uphold cross-site relationships with other Thermo Fisher Scientific sites to develop and sustain collaboration and standard processes
Skills
cGMP
Validation Engineering
Process Engineering
Tech Transfers
Equipment Readiness
KPI Management
Risk Registers
GMP Safety Standards
Manufacturing Processes
Engineering Leadership
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees