Validation Engineer - Bethlehem, United States - Sharp Corporation

Description

Summary

Responsibilities include drafting and executing Validation and Qualification Protocols related to cleaning, equipment, computers, process and facilities as well as drafting Summary Reports for executed protocols at the direction of the Manager, Validation Engineering.

Secondary responsibilities include drafting Validation Qualification Protocol Events encountered during protocol execution. Responsible for ongoing contact with Packaging Engineering, Operations, Quality Assurance, Project Management, and customers regarding validation activities and scheduling. The duties of this position directly impact company compliance to regulatory requirements and customer satisfaction.

Essential Duties and Responsibilities

The following is a list of minimum responsibilities related to this position. Other duties may be assigned.

Generate and execute, with the support of key stakeholders, validation protocols, qualification protocols, and summary reports inclusive of cleaning validation, process validation, computer systems validation, design qualification, installation qualification, operational qualification, and performance qualification as appropriate.

Perform quality engineering reviews of design documentation for compliance with stated requirements including vendor quality manuals and company quality records.

Ensure all validation activities are up to date in accordance with Good Validation Practices and cGMP.
Review maintenance requests and work orders to assess impact of work to existing qualified state.
Support key internal stakeholders on review of new equipment, process, and system requests and assess for validation requirements.
Participate in customer audits and regulatory inspections.
Author, review, and/or approve SOPs and policies related to validation processes and equipment.
Draft Confirmation of Changes for appropriate equipment, systems, and processes within guidelines of cGMP and GAMP
Maintain compliance with cGMP and all competent authority guidelines by regularly reviewing and adhering to SOPs.
Adhere to set safety standards.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Bachelor's Degree and 5+ years of relevant experience OR Associate Degree and 10+ years of relevant experience.
Thorough knowledge of and proven experience in validation role within the clinical, pharmaceutical, or R&D environment.
Cleaning validation experience strongly preferred.
Demonstrated ability to work independently, handle multiple tasks simultaneously, and meet internal and external customer timelines.
Ability to work in a cross-functional / matrix environment.
Strong oral and written communication skills.
Ability to follow and interpret cGMPs, FDA, DEA, OSHA and ISO regulations and guidelines.
Working knowledge of personal computers and Microsoft Office Products, including Word, Project, and Excel.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands to handle or write to speak and hear.

The employee frequently is required to sit. The employee is regularly required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

Environmental Conditions

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

While performing the duties of this job, the employee is normally required to sit at a desk and frequently go onto the shop floor and to work in close proximity to packaging equipment.

The working environment is clean and not normally subject to hazardous environment or conditions.

This position is afforded the benefit of working in a hybrid arrangement. This role must have an on-site presence, averaging at least three (3) days on site on a weekly basis.

Business needs may require this position to be onsite more than three (3) days per week with or without notice.

Working remotely must be done in a dedicated, quiet workspace with minimal distractions and/or interruptions.
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