Senior Engineer (Pilot Operations)
Senior Engineer (Pilot Operations)
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1 Vacancy
Job Description
At Alcon we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly champion progress and act with speed as the global leader in eye care. Here youll be recognized for your commitment and contributions and see your career like never before. Together we go above and beyond to make an impact in the lives of our patients and customers.
We foster an inclusive culture and are looking for diverse talented people to join Alcon. As a Senior Engineer supporting R&D in Fort Worth TXyou will be trusted to ensure current aseptic operations in R&D cleanroom is in compliance with regulatory cGMP and Alcon Quality requirements.
In this role a typical day will include:
Perform compounding and filling operations with little or no supervision in lab and/or pilot scale to support R&D new product development including formulation and material fabrication sample testing and documentation under design control and Alcons quality system.
Assist with aseptic process qualification: Lead hands-on qualification of aseptic processes to ensure sterile manufacturing including monitoring environmental controls and process compliance.
Responsible in inventory control and release.
Lead GxP lab and cleanroom management pilot line development and qualification activities as well as preventive maintenance.
Conduct risk assessments and lead risk management activities: Directly execute and oversee risk assessments identifying potential risks for pilot equipment and aseptic processes and implement mitigation strategies to ensure regulatory compliance.
Has knowledge and experiences in formulation preparation familiar with related equipment such as preparing solutions emulsions and gel at pilot and manufacturing scale.
Have strong knowledge and experiences in operating under aseptic conditions and provides training to pilot associates on new products and/or processes.
Have strong knowledge and experiences in GDP GMP requirements and perform with high quality.
Be the subject matter expert of aseptic techniques and operations.
Support pilot equipment qualification (IQ OQ PQ): Execute the development and implementation of qualification protocols (installation operational performance) for pilot equipment and lab assets ensuring proper operation and regulatory compliance.
Lead non-conformance investigations perform root cause analysis and implement corrective and preventive actions (CAPA) in line with regulatory and GMP standards.
Initiate and drive value add improvements for the efficiency of the group.
Be pro-active positive ability to work under pressure and handle multiple assignments.
Be able to follow instructions; be a self-starter and demonstrate active strong problem solving capability.
Proven ability to interact confidently and to communicate effectively both face to face and in writing with internal and/or external contacts.
Stay focused at tasks effectively manage time to support daily lab priorities in addition to special projects.
Work cross functionally including Quality partners equipment and utility SMEs and facility as well as with applicable vendors to meet target validation timelines.
Prepare and review technical documentation: Prepare review and approve validation protocols reports and documentation ensuring they are complete accurate and in compliance with regulations.
Experience:
5-7 years of experience in Manufacturing Operations with at least 3 years focused on production filling in regulated environments (e.g. pharmaceutical biotech medical device) strongly preferred.
Strong knowledge of GMP FDA EMA and other relevant regulatory requirements.
What Youll Bring to Alcon:
Bachelors Degree or Equivalent year of directly related experience (or high school 13 yrs; Assoc. 9 yrs; B.S. 5yrs; M.S. 2yrs; PhD 0yrs)
The ability to fluently read write understand and communicate in English
2 yrs of relevant experience
How You Can Thrive at Alcon:
Join Alcons mission to provide outstanding innovative products and solutions to improve sight improve lives and grow your career!
Alcon provides robust benefits package including health life retirement flexible time off and much more!
Travel Requirements: 0-5%
Relocation assistance: No
Sponsorship available: No
Alcon Careers
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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.
Required Experience:
Senior IC
Employment Type
Full-Time
