Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Specialist Quality Control

Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.

Key Responsibilities:

• Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
• Resolve technical issues and troubleshoot for assays as necessary
• Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
• Manage existing and/or develop and implement new programs, processes and methodologies.
• Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
• Approve lab investigations, Lead audit teams
• May serve as subject matter expert to develop technical training.
• May perform routine work in a specific area of responsibility as necessary.
• Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.
• May interact with regulatory agencies regarding area(s) of responsibility including written responses.
• May resolve issues with outside resources.
• Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.

Qualifications:

• Bachelor's Degree in Engineering or Science.
• Minimum of 4 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.

Skills:

• Strong Technical Writing (English and Spanish) mainly focuses
• Excellent communication skills, facilitation and presentation skills.
• Strong knowledge in Microsoft Excel as a Tool for Data Analysis
• Knowledge in Computer System and Method Validation (Experience preferable)
• Strong knowledge and experience with quality process management
• Knowledge on equipment validation and troubleshooting (Experience preferable))
• Agile on prioritization of critical tasks
• Ability to develop inspection or qualification protocols in a short timeframe period.
• Strong negotiation skills
• Usage of KNEAT platform and Kaye validator (Experience Preferred)
• Strong computer operation skills including work processing, presentation, database and spreadsheet application skills.
• Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
• Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
• Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
• Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
• Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
• Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
• Ability to evaluate compliance issues.
• Skill in evaluating and documenting according to Company and various guidelines.
• Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
• Advanced scientific data analysis and interpretation skills.
• Advanced skills in solving complex problems.
• Advanced data trending and evaluation.
• Strong skill in working independently and to effectively interact with various levels.
• Initiate, coordinate and lead cross functional teams.
• Excellent skill in leading, motivating, influencing, and negotiating.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.