Senior Engineer – Pilot Operations

Senior Engineer – Pilot Operations

Requirements

• 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.
• Bachelor’s 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

Responsibilities

• 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 Alcon’s 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.

Preferred Qualifications

• Strong knowledge and experiences in GDP, GMP requirements, and perform with high quality.