Allied Reliability is seeking a Process Control Technologist for Pharmaceutical Manufacturing in Syracuse, NY.
Responsibilities of a Process Control Technologist include: design, conduct, and report validation studies for critical equipment and processes in a pharmaceutical manufacturing environment including IQ, OQ, PQ, Process Validation, and Cleaning Validation. Successful candidate will research processes, define critical variables and operating ranges, research guidelines and regulatory requirements, and write protocols in accepted format. Coordinate execution of validation studies with Production, QA, QC, and all other appropriate internal departments. Perform test runs in compliance with the protocol and complete proper documentation. Compile and analyze data collected during test runs, including laboratory test results. Review, interpret and analyze data. Create graphs, charts or tables and compile support documentation. Write validation summary reports. Complete Validation Confirmations, Continued Process Verification, and revalidation studies to maintain current validation status. Research documents and records needed to complete confirmations. Monitor and revise production documents for conformance with validations.
Education & ExperienceBachelor's degree in sciences or equivalent, Master's degree preferred. 3-7 years in pharmaceutical validation/process control field.
Knowledge, Skills & Abilities- Knowledge of contemporary validation and calibration practices and procedures.
- Knowledge and skill in using computer software, to include databases, spreadsheets, and word processing.
- Knowledge and skill in operating various specialized equipment, such as temperature data loggers and calibration equipment.
- Knowledge of validations for pharmaceutical process and equipment.
- Knowledge of cGMPs, industry standards and validation guidelines.
- Ability to pay close attention to detail and coordinate various activities simultaneously.
- Ability to communicate with coworkers, management team members, and other individuals in a courteous and professional manner.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
- Ability to compute rate, ratio, and percent and to draw and interpret graphs.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and subordinate instructions.
- Ability to effectively present information and respond to questions from managers, coworkers, and other individuals.
- To develop plans, analyze plan processes and results, develop hypotheses, execute tests and analyze data.
