Quality Validation Engineer - Dexian : Job Details

Job Title: Quality Validation Engineer

Duration: 6+ Months (Possibility of Extension & Conversion depending on Performance)

Location: Grand Island, NY 14072

Work Arrangement / Schedule: 1st shift M-F with flexibility on start/end time, with support needed around manufacturing schedule (some early days, some late nights, some weekends as needed but each would be communicated in advance and also have shared support with FTE staff), OT is optional but available especially as candidate becomes more trained to work independently.

Pay range: $23-25/hr on W2

Job Overview:

Summary:

• The primary responsibility of this position is for support of qualification documentation filing, preparation or any responsibility surrounding data collection.
• Other department tasks may involve thermocouple assembly / calibration, data collection, system updates and other tasks as assigned.
• Preferred excellent written and verbal communication skills, and ability to maintain cGMP compliance in accordance with worldwide guidance sources.

Position may perform the following:

• Documentation
• Analytical assessment
• Data gathering.

Job Responsibilities:

• Collects current equipment documentation to fill gaps or identify missing information.
• Working with Validation Engineers and quality assurance document control to implement necessary improvements.
• These may include modifications to existing documents, or collection and filing of current documents.
• Supports validation protocols for data collection, or creating documents, as assigned.
• Maintains compliance with regulatory agency guidance and Client's procedures.
• Assists with execution of equipment validation studies to include protocol execution, data analysis up to including control system administration such as software backups and system updates.
• Programs and operate department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Drafts commissioning and qualification protocols to sufficiently demonstrate the process is designed and fit for the intended use
• Supports on-going system requalification and continuous improvement activities governed by change management processes

Skills:

• Possess an understanding of documentation organization, and ideally in a GMP environment
• Must have excellent verbal and written communication skills, attention to detail, and problem-solving skills.
• Must be experienced with Microsoft Office tools, i.e. Word, Excel, etc.
• Desirable to also have some basic mechanical skills.
• Preferred understanding of statistical analysis tools and/ or analytical methods.

Education/Experience:

• BS/BA Degree in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility.
• 0 - 2 years pharmaceutical manufacturing experience.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.