Sr. Associate I, Manufacturing Science & Technology Engineering at Alcon

Houston, Texas, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Eye Care, Medical Devices, ManufacturingIndustries

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
The ability to fluently read, write, understand and communicate in English
2 Years of Relevant Experience
Previous experience in EO and Gamma Sterilization modalities
Preferred: Strong knowledge of EO, Gamma, E-Beam and X-ray sterilization modalities
Preferred: Project Management

Responsibilities

Design and approve sterilization processes including EO parametric requirements, DEO, SLR and cycle calculations
Lead and execute validation activities (IQ, OQ, PQ) for EO and Gamma sterilization modalities
Design dose mapping studies for Gamma sterilization
Develop and manage annual ethylene oxide (EO) sterilization requalification protocols and reports
Evaluate new components for sterilization compatibility based on animal tissue, microbiological and EO residues assessment
Review and assess engineering protocols related to microbiology and sterility testing, raw materials, packaging components, and vendor qualifications
Investigate sterilization failures at contract facilities, identify true root causes, and implement/track CAPAs within the Quality System
Perform statistical analysis to assess process control and manage risks related to product sterility
Support design control activities with sterilization-related risk documentation
Design and analyze sterility testing and EO residue methods
Support external audits of sterilization vendors to ensure compliance with 21 CFR, ISO 13485, and GMP requirements
Interpret and apply relevant standards and guidance documents including ISO 11135, ISO 11137, ISO 11737, AAMI TIRs (15, 17, 28), and FDA/country-specific regulations

Skills

Sterilization Process Development

EO Sterilization

Gamma Sterilization

Validation IQ OQ PQ

Dose Mapping

Requalification Protocols

Microbiological Assessment

Statistical Analysis

CAPA

Risk Management

Quality Compliance

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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