Process Engineer I

8/4/22

Baltimore, MD

1784

Responsible for developing, scaling up and validating processes used for producing specialty drug delivery products in a manner compliant with 21CFR211 and all other relevant regulatory requirements.

Responsibilities:

  • Develops modified and new processes for producing specialized drug delivery therapeutic products. Works in close collaboration on cross-functional teams with R&D, Quality, Operations, Marketing and Clients to accomplish successful outcomes.
  • Performs a variety of engineering tasks with Senior Engineer guidance, which include but are not limited to preparation of experimental and validation protocols and execution thereof in chemical processing, coating and slitting/finishing areas in compliance with 21CFR211 Regulatory standards.
  • Contributes to designing experiments, conducts experiments, collects data and performs data analysis and interpretation. Generates reports and makes recommendations based on sound data interpretation.
  • Generates design records required to support product development and commercial production.
  • Accurately performs work assignments and computer data analysis.
  • Effectively communicates and interacts with other associates and customers.
  • Participates in problem-solving efforts.
  • Proactively works to develop foundational knowledge base on relevant process technologies.
  • Develops and maintains awareness of business strategies and plans.
  • Conducts all work activities in a safe, responsible and professional manner consistent with all Company Policies, Quality Systems Requirements and Relevant Regulatory Standards (e.g. 21CFR211).
  • Conducts deviation investigations; develops and implements preventative actions.
  • Participates in training.
  • Performs other duties and responsibilities as assigned.

Requirements:

  • Bachelors degree in an Engineering (Chemical preferred).
  • cGMP manufacturing environment experience desirable.
  • Engineering principles, concepts and methodology foundational knowledge and ability to practically apply them.
  • Capable of learning practical application of engineering skills in areas including but not limited to LEAN manufacturing principles, design control, validation, experimental design, etc.
  • Excel, Word, PowerPoint, Outlook, Statistical software package capability.
  • Ability to effectively organize thoughts, information and data; can articulate and convey them (oral and written) concisely and clearly to others.
  • Ability to manage several priorities simultaneously.
  • Time flexibility to occasionally work extended hours and/or different shifts as programs and business demands. Must be able to travel as needed to support the business (<25%).
  • Work environment may involve moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, chemical irritants; may be required to use personal protective equipment such as masks, uniforms, blues, hairnets, gloves, safety glasses/goggles, shields, etc.
  • Ability to function effectively with others in a team environment.

Apply Now