Principal Engineer

3 weeks ago

Fort Worth, United States Alcon Full time

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, you’ll 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.

The purpose of the Principal Engineer, Aseptic Suite Specialist for R&D Ocular Health role is to lead activities aimed at designing, enhancing, and maintaining the R&D Ocular Health Pilot Aseptic Suite in Fort Worth, TX, with a focus on improving contamination prevention programs and microbiological hygiene initiatives.

In this role the candidate leads the design, enhancement, and maintenance of the Pilot Aseptic Suite, with a primary emphasis on improving contamination prevention programs and microbiological hygiene initiatives. Serving as the SME on pilot aseptic procedures, conducting thorough investigations into microbiological contamination issues and provide actionable solutions. Collaborating closely with the Alcon Aseptic and Microbiology communities, develop and sustain contamination control risk assessments and strategies aligned with industry standards. Responsibilities will include leading continuous process improvement efforts, providing guidance on aseptic validation strategies, and overseeing the environmental monitoring program. Additionally, they actively participate in pilot productions, ensuring compliance with documentation and standards, and fostering effective collaboration within the organization.

Accountabilities:

  • Collaborate closely with the Alcon Aseptic and Microbiology community, lead activities aimed at designing, enhancing, and maintaining the R&D Ocular Health Pilot Aseptic Suite, with a focus on improving contamination prevention programs and microbiological hygiene initiatives.

  • Serve as the primary subject matter expert on pilot aseptic procedures, conducting investigations into microbiological contamination issues within the facility. Offer practical solutions and guidance to pilot production, aseptic validation leaders, and management to prevent contamination risks.

  • Partner with Alcon Aseptic and Microbiology communities to develop and sustain contamination control risk assessments and strategies for the Ocular Health R&D Pilot Aseptic Suite. Ensure alignment with cGMP, Annex 1, Alcon, and regulatory standards. Drive continuous improvements in contamination risk reduction and microbiological hygiene practices, overseeing their implementation. Provide guidance on aseptic technique and operator behaviors to mitigate cross-contamination risks.

  • Lead a continuous process improvement program for the aseptic program in collaboration with process development, pilot production, and quality assurance teams.

  • Work closely with aseptic validation associates, providing guidance on aseptic validation strategy, and actively participate in and support validation activities.

  • Support the pilot production, provide technical leadership and guidance in managing the environmental monitoring program. Conduct proactive, periodic reviews and analyses of microbiological and particulate site trends, including critical utilities and environments. Lead investigations into excursion incidents in laboratory and process settings. Collaborate closely with testing laboratories on microbiology and contamination control test requirements and trend analysis.

  • Collaborate with the pilot production, design, maintain, and deliver a comprehensive aseptic technique and microbiology training program to enhance training related to microbiological hygiene and contamination prevention.

  • Actively participate in and support pilot preclinical and clinical productions. Ensure the review, approval, and updating of relevant documents, including Standard Operating Procedures (SOPs) and Work Instructions (WIs).

  • Network and coordinate with Microbiology and Contamination Control partners within Alcon microbiological communities to proactively monitor safety policies, quality systems, cGMP requirements, regulatory standards, and best practices. Ensure compliance, foster effective collaboration, and promote knowledge sharing.

  • Demonstrate excellent teamwork, communication, scientific writing and interpersonal skills.

  • Work independently with initiative, self-drive, and strong prioritization skills with sense of urgency, demonstrating problem-solving abilities and maintaining responsibility for deliverables.

  • Adapt to business needs, showcasing leadership in efficiency and effectiveness while striving for excellence.

Key Requirements/Minimum Qualifications:

  • Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)

  • The ability to fluently read, write, understand and communicate in English

  • 5 Years of Relevant Experience

  • Travel Requirements: 0-5%

  • Work Hours: M-F, standard

  • Relocation assistance: Yes

  • Sponsorship available: Yes    

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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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

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