Qualification Engineer, Infrastructure
3 weeks ago
Title: Qualification Engineer, Infrastructure
Duration: Long Term rolling contract
Location: On site preferred in Philadelphia, PA - East Coast required
Specific Job Responsibilities
Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.
Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.
May also investigate and trouble-shoot problems which occur and determine solutions.
Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
Maintains all documentation pertaining to validation.
Will assist in developing procedures and/or protocols.
Coordinates contract personnel through completion of assignments.
Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
Knowledge, Education & Experience
Understanding and application of validation principles, concepts, practices, and standards.- 8+ years
Working knowledge of current Good Manufacturing Practices (GMPs).
Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical environments.
6+ years qualifying infrastructure and OT networks
Working knowledge of validation of process control (PCS) and data acquisition systems is preferred.
Strong verbal, written, and interpersonal communication skills.
Proficient in Microsoft Office applications.
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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