Edison-New Brunswick Metro Area, NJ
Carries out responsibilities in accordance with the organization s policies, procedures, and state, federal and local laws.
Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
Assures that protocols are approved through proper channels; writes and revises validation protocols.
Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
Analyzes new and existing equipment, recommends equipment modifications as needed for validation optimization.
Assures that all test data is gathered and recorded in accordance with cGMP requirements.
Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria.
Writes final reports and assures that they are approved through proper channels.
Performs necessary equipment and system IQ, OQ, and PQ's to assure compliance in all manufacturing and support areas.
Develops and communicates project timelines and status.
Complies with all GMP and safety requirements, SOP s and Company policies and procedures.
Performs related duties as assigned.
Work in self-directed manner and must be able to work on problems of a complex scope where analysis of data requires and in-depth evaluation of various factors
Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Demonstrated understanding and use of statistical methods in experiment design, data analysis, validation, and process monitoring
Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
Pharmaceutical principles, practices and applications.
English usage, spelling, grammar and punctuation.
Principles of mathematical and statistical computations.
Personal computer operations and Microsoft applications (Word, Access, and Excel).
Interpreting software and ladder logic diagrams and flowcharts.
Interpreting electrical and mechanical blue prints and specifications including HVAC systems and. construction plans.
Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.
Communicating clearly and concisely, both orally and in writing.
Establishing and maintaining good relationships with those encountered in the course of work.
Physical Requirements and Working Conditions:
Incumbents in this class are subject to extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up to 25 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment. Work is performed in a manufacturing environment.
Minimum Qualifications: Bachelor s degree in Engineering or a related field from an accredited college or university and zero (0) to one (1) year of engineering validation experience, preferably in a pharmaceutical environment, or an equivalent combination of training and experience.