NPI Validation Engineer
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers. Are you ready to join us
Associate Validation is primarily responsible for handling technical tasks in the Validation discipline including planning executing and documenting validation studies conducting risk assessments designing protocols and preparing validation reports. You will support validation activities and collaborate with cross-functional teams. Specifics include:
Handle technical tasks supporting operations and contributing to efficiency within defined procedures
Plan execute and document validation studies to ensure equipment systems and processes operate effectively and comply with regulations
Conduct risk assessments design protocols analyze data and prepare validation and qualification reports to verify that products and processes meet predefined criteria
Operate within defined procedures with some decision-making authority requiring technical skills task management and adherence to procedures
Review and approve change control documentation
Provide audit support
Collaborate with cross-functional teams to drive problem-solving and innovation through scientific principles
Requirements:
- Min bachelors degree in engineering/automation
- 2 years relevant experience in highly regulated industry with complex product lines. Optics most preferred.
- Hands-on approach with a strong ability to work directly on equipment and processes.
- Self-starter who can work independently and take initiative in problem-solving and process improvement.
- Commitment to compliance safety and continuous improvement.
- Strong communication and ability to work collaboratively in a team environment
- Ability to learn quickly and adapt to changing environments
- Commitment to high-quality work and continuous improvement
- Positive attitude and willingness to take on new challenges
- Relocation/ Visa Sponsorship Assistance: No
Applicant must have full Australian work rights.
Candidate must possess strong knowledge of equipment and process validation (IQ/OQ/PQ) as well as component and other change verifications including the ability to write clear testable user and functional requirements for complex manufacturing workstations and processes.
Someone has a good mindset of good documentation - technical documentation is a key. Controlled manufacturing. Performing equipment and process qualifications on new or updated equipment to ensure compliance quality and ability to ramp manufacturing processes.
Highly valued: Experience with automation precision assembly processes and equipment optics or complex multistep workstations.
What We Offer
Competitive salary and benefits package.
Opportunities for professional growth and development.
Inclusive and innovative work environment.
The chance to make a meaningful impact on global eye health.
Alcon Careers
See your impact at Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.
