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
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Medical DevicesIndustries
Requirements
- Afgeronde bachelor- of masteropleiding in Ingenieurswetenschappen
- 3–5 jaar ervaring met projectmanagement en validatie, bij voorkeur in de farmaceutische industrie, productieomgeving of medische hulpmiddelen
- Goede kennis van GMP en basiskennis van informatica
- Kennis van CSA/CSV-validatie is een pluspunt
- Brede interesse in industriële automatisatie, software en productieapparatuur
- Uitstekende beheersing van Nederlands en Engels
- Analytisch denkvermogen en probleemoplossende skills
- Hands-on mentaliteit en flexibiliteit in een omgeving waar nog niet alles vastligt
- Sterke communicatieve vaardigheden en proactieve houding
Responsibilities
- Coördineren en uitvoeren van validaties voor geautomatiseerde systemen (URS, risk assessments, testprotocollen, rapporten, change control-documentatie)
- Ontwikkelen van templates en standaarddocumentatie voor toekomstige validatieprojecten
- Ownership nemen in een dynamische omgeving met snel veranderende prioriteiten
- Samenwerken met interne en externe stakeholders zoals automatisatie-experten, leveranciers, productie en QA
- Ondersteunen van het validatiebeheer van het externe ETO-sterilisatieproces
- Meewerken aan root cause onderzoeken en implementatie van CAPA’s
- Uitvoeren van SOP-reviews en deelnemen aan interne audits
- Actief bijdragen aan een veilige werkomgeving en HSE-doelstellingen
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the compensation for the Validation Engineer role?
The position offers an attractive salary supplemented with extra-legal benefits.
Is this Validation Engineer position remote or on-site?
This information is not specified in the job description.
What skills and experience are required for the Validation Engineer role?
Candidates need a bachelor's or master's in engineering, 3-5 years in project management and validation (preferably pharma/production/medical devices), good GMP knowledge, basic IT knowledge, analytical thinking, problem-solving, hands-on mentality, flexibility, strong communication, and proactivity. Dutch and English fluency are required, with CSA/CSV validation as a plus.
What is the company culture like at Alcon for this role?
Alcon promotes an inclusive culture in a dynamic environment where initiative, flexibility, and contributions are valued, with a focus on impactful work in eye care innovation.
What makes a strong candidate for the Validation Engineer position?
Strong candidates have 3-5 years of validation and project management experience in pharma or production, GMP knowledge, analytical and problem-solving skills, hands-on flexibility, and proactive communication in Dutch and English.
Alcon
Specializes in eye care products and solutions
About Alcon
Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.
Geneva, SwitzerlandHeadquarters
1945Year Founded
IPOCompany Stage
Social Impact, HealthcareIndustries
10,001+Employees
Benefits
Medical, dental, & vision coverage
HSA Medical Plan
PTO
Paid Parental leave
401k
Retirement Plan Company Contribution
Low payroll deductions
Tuition Reimbursement Program
Annual Bonus
Free Family Contact Lens Program
12 Company Paid Holidays
Risks
FDA recall of contact lenses may harm Alcon's reputation and financial standing.
Antitrust case denial could lead to legal challenges and financial penalties.
Innovative competitors like Signal12 threaten Alcon's market share in eye care.
Differentiation
Alcon leads in eye care with a broad product portfolio and global reach.
The company invests heavily in R&D, ensuring cutting-edge vision solutions.
Alcon's commitment to diversity and inclusion strengthens its corporate culture.
Upsides
Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.
Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.
Recognition as a top employer in Singapore attracts and retains top talent.
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