Validation Engineer I
Dunkirk , NY 14048
Posted 2 weeks ago
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POSITION OBJECTIVE: Responsible for providing lifecycle support of validation functions related to isolated filling lines, lyophilization, terminal sterilization, autoclave, manual aseptic operations, packaging, and serialization.Provides continued technical support to the operations team in equipment, system, utility, facility, and process initial validation and continued requalification efforts. Participates in equipment procurement, validation, and maintenance of the validated state.Participates in improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must have a working understanding of cGMPs. The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties.
Essential Job Functions/Responsibilities
- Works with user groups to assemble and produce User Requirements Specifications for manufacturing equipment and laboratory instrumentation- 5%.
- Prepares and executes equipment specific documents: Factory Acceptance Tests and Site Acceptance Tests- 5%.
- Works with manufacturing processes involved in tablet compression, granulation and tablet coating and test instruments, such as friability tester and dissolution testing. Qualification of equipment related to tableting- 20%.
- Preparation and execution of Cleaning Validation Protocols; determination of cleaning validation residue limits based on lethal dose and acceptable daily intake, proficiency in swab sampling for Total Organic Carbon method of analysis- 20%.
- Follows approved SOPs and policies to prepare qualification documentation and when performing documentation activities- 5%.
- Prepares and executes documentation for Installation, Operational and Performance Qualification protocols, facility and critical classified area protocols, computerized systems, cleaning validation protocols, media fill validation protocols.Equipment includes: isolated filling lines (ex., syringe, IV bag, vial), lyophilizer, parts washer, autoclave, formulation tanks and their related process control systems.Utilities systems include:Water for Injection, Clean Steam, Oil Free Compressed Air, Clean-in-Place. Supporting equipment includes Water for Injection Point of Use Coolers. Facilities Monitoring System, Environmental Monitoring System, utilities SCADA systems- 10%.
- Coordinates and communicates all required testing with affected functional groups and evaluates test results. Accurately records and evaluates test results and observations- 5%.
- Analyzes data, composes a final report and circulates for approval.Resolves comments provided by reviewers entirely and in a timely manner- 5%.
- Maintains ongoing schedule by performing equipment requalification and performance qualifications per Standard Operating Procedures (SOPs)- 5%.
- Supports Regulatory Agency inspections when necessary- 3%.
- Programs and operates department instrumentation (such as temperature/humidity dataloggers, aerosol smoke generators, photometers, velocity meters) to perform controlled temperature/humidity chamber qualifications (examples: environmental chambers, lyophilizers, warehouses, sterilizers, incubators, coolers, and freezers, etc.), airflow visualization testing and documentation for aseptic processes- 3%.
- Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards- 5%.
- Conducts Validation deviations- 2%.
- Provides information and participates in deviation investigation teams to identify root causes and define corrective and/or preventative actions (CAPA)- 2%.
Required Education and Qualifications
- Masters degree in Pharmaceutical Manufacturing or Engineering, Chemical Engineering or Biomedical Engineering
- 1 year of experience working in an FDA regulated facility as a Validation Technician, Quality Control Analyst or Quality Engineer.
- Requires domestic travel up to 10% of time to other Athenex offices and to vendor sites.
Athenex is an equal opportunity employer.We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities.If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.