In order to be considered for this position candidates MUST have:
Green card or US citizen - NO SPONSORSHIP OFFERED
Pharmaceutical Validation Engineering Experience
POSITION SUMMARY
Responsible for the oversight and evaluation of procedures used in the development and production of products ensuring safety, quality, and purity requirements are met. Leads activities to develop and improve manufacturing processes by studying product and manufacturing methods, preparing analyses reports, presenting information and making recommendations to solve problems and/or improve processes. Works closely with project management team to ensure efficient, effective and timely execution of projects.
PRIMARY DUTIES & RESPONSIBILITIES
Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.
Prepares protocols for validation or performance testing of new or modi?ed manufacturing equipment, processes, or systems.
Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
Collaborates and coordinates with appropriate departments and sta? regarding the scheduling or implementation of validation testing.
Develops and maintains databases for tracking test results, validation activities, or validated systems.
Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notes.
Equipment Qualification - development of validation protocols, testing execution and writes validation reports. This includes FATs, URSs, DQs, SATs, CTPs, IQs, OQs, PQs,
and other validation life cycle documents.
Cleaning and Process Validation - assists/performs cleaning and process validation at the
site.
Adhere to all company and GMP procedures, along with safety regulations within the plant.
Assist with the Site Change Management Program to keep all finished products,
equipment, processes and facilities in compliance with contemporary industry standards
and regulatory filings.
Develop a strong documentation package, involving pre-commissioning/commissioning of
equipment, Qualification and documentation
Conduct regular project review meetings within the team, with cross functional teams and
with the vendors to control the project(s) time to time.
Stay current with industry qualification trends through FDA, ISPE, EU, PDA and bench
marked companies.
Modi?es testing methods or revisits test objectives and standards to resolve testing problems.
Performs other related dues as assigned
Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.
Maintains product and company reputation by complying with government regulations.
Coordinates interdepartmentally on projects to ensure alignment and consistency on project management across both sites while adhering to Quality, Compliance, Safety, and Production Standards.
EDUCATION & EXPERIENCE
Bachelor's degree in related ?eld required.
5 Years' experience as a manufacturing and/or validation engineer
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