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MV01-031026 Technical Services Scientist

Validation & Engineering Group, Inc
locationUnited States
PublishedPublished: 6/14/2022
Science
Full Time

Job Description

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.

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