Software Engineer, Simulation
AeroVectSalary not specified
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, BiotechnologyIndustries
Requirements
- Degree in Pharmacy, Chemistry, Biotechnology, Biology, similar scientific degrees or consolidated experience
- Previous experience in validation is helpful
- Proficient English (both written and spoken)
- IT knowledge: Company IT systems (PMX, LIMS, Trackwise, Minitab) and Microsoft Office tools
- Personal skills: Excellent interpersonal skills, proactivity, ability to work in a team
Responsibilities
- Issuing validation procedures, protocols and reports for Media Fill exercises
- Processes design: Object of APS are manufacturing of sterile lyophilized and liquids drug products (vials, pre-filled cartridges or syringes), manufactured under RABS systems or isolators
- Analysis of technical documentation related to new product introduction
- Issue of manufacturing instructions (MBR) for validation batches
- Ensure that our client service delivery performance is maintained at the highest level, by encouraging positive relationships with our clients and coordinating activities to ensure the clients are kept informed in a timely manner
- Issue of technical reports and risk assessments related to operator qualification, qualified holding times, aseptic interventions
- Guarantee that all relevant activities are adequately evaluated and handled through change control management
- Clients and Regulatory audits with regards to Media Fill activities
- Ensure an adequate reporting to the Area Management about potential issues
- Support the Supervisor, MS&T Process & Cleaning Validation in ensuring the management of the aseptic process validation, leading Aseptic Process Simulation (APS) documentation and guide on the floor operations, in close contact with technical and sterility assurance teams, and in accordance with Regulatory mentorship
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What qualifications are required for the Aseptic Process Validation Specialist role?
Candidates need a degree in Pharmacy, Chemistry, Biotechnology, Biology, or similar scientific degrees, or consolidated experience. Previous experience in validation is helpful, along with proficient English and IT knowledge of systems like PMX, LIMS, Trackwise, Minitab, and Microsoft Office.
What is the work schedule and location for this position?
It's a full-time standard Monday-Friday schedule in an office environment at the Monza site.
What are the main responsibilities of the Aseptic Process Validation Specialist?
Key tasks include issuing validation procedures, protocols, and reports for Media Fill exercises, designing processes for sterile drug products under RABS or isolators, analyzing technical documentation for new products, issuing manufacturing instructions, technical reports, risk assessments, and supporting audits.
What is the company culture like at Thermo Fisher Scientific?
The company emphasizes values of Integrity, Intensity, Innovation, and Involvement, with a dynamic team environment where diverse experiences and perspectives are welcomed, working together as one team of 100,000+ colleagues.
What personal skills are needed for this role?
Excellent interpersonal skills, proactivity, and the ability to work in a team are required.
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
Risks
Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.
Differentiation
Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.
Upsides
Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.
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