Validation & Engineering Group, Inc.

Technical Services Scientist

Validation & Engineering Group, Inc.  •  Carolina, PR (Onsite)  •  7 days ago
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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:

  • Technical Services Scientist

Responsibilities:

  • Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines, this position has the following tasks and duties.
  • Provide technical oversight for spray dry and solid dosage manufacturing processes, leveraging a strong technical foundation and previous experience supporting these processes.
  • Participate in resolution of technical issues, including those related to control strategy and manufacturing.
  • Authoring of deviations and change controls.
  • Build, manage, and maintain internal and external relationships, site management, development and central technical organization, and cross-functional teams.
  • Ensure that manufacturing processes are compliant, capable, in control, and maintained in a validated or qualified state.
  • Understand, justify, and document the state of process validation with data that evaluates the capability of the manufacturing process to meet its stated purpose.
  • Maintain processes in a state of compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance.
  • Support ongoing manufacturing at External Partners through process monitoring, issue response, and process improvements where necessary.

Requirements:

  • Bachelor's degree (minimum) in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering.
  • 3+ years of demonstrated hands-on working experience and proficiency with spray dry and/or solid dosage manufacturing.
  • Strong understanding of regulatory requirements, their application, and expectations in a manufacturing environment (cGMPs and applicable global regulatory guidance).
  • Proficient in data management practices across manufacturing operations.
  • Proven ability to effectively communicate and influence across diverse teams.
  • Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects.
  • Available to support 24/7 operations and issue resolutions across multiple time zones as needed.
  • Excellent technical writing capabilities and documentation in English, and communication skills.
  • Ability to manage multiple priorities and work independently with limited supervision
  • Available to work extended hours, possibility of weekends and holidays.

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.

Validation & Engineering Group, Inc.

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Proudly serving our clients since 1997.

Our Mission states in part: "provide our clients with the best resources to meet their needs". In our search for the best talent, we are inclusive and do not discriminate. V&EG is proud to be an equal opportunity workplace and is an affirmative action employer.

Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.

Our agility in responding to our clients’ needs, access to the best pool of talent, and the combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries.

At Validation & Engineering Group we provide professional expertise in the areas of:

•Audit and Assessment

•Automated Process Control System Qualification

•Equipment and Facilities Qualification

•Facilities Start-Up and Commissioning

•GAP Analysis

•Information Systems Computer Validation

•Packaging and Process Analysis

•Process & Cleaning Validation

•Project Management

•Quality Systems

•Risk Based Approach

•Regulatory Compliance

•Standard Operating and Maintenance Procedures

•Training

•Utilities Support and Qualification

In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical.

Our Offices:

Puerto Rico:

Centro Internacional de Mercadeo I 100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico

Phone: (787) 622-0996

United States:

2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States

Phone: (770) 403-5802

Industry
Architecture & Engineering
Company Size
51-200 employees
Headquarters
Guaynabo, PR
Year Founded
1997
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