Engineer - Process Automation

Location: East Windsor, NJ

Aprecia is a specialty pharmaceutical company committed to transforming customers' experience with highly prescribed high-dose medications. Built upon our proprietary three-dimensional printing (3DP) technology platform, we develop and manufacture pharmaceuticals and imagine a world where oral medications are no longer challenging for patients to take or for caregivers to give. Additionally, we inspire each other every day to seek innovative solutions that address administration and adherence needs.

General Purpose of Position:
Provide mechanical and electronic automation expertise for the design, development, installation, and validation of Aprecia’s 3DP-based (three dimensional printing) solid dosage manufacturing equipment.  Responsible for expanding and supporting the technology platform for Aprecia’s product development programs.  Supports the mechanical and control systems aspects of the development of new (or changes to existing) pharmaceutical manufacturing equipment intended for production or product development.  Depending on project scope, will be a team member or may take project ownership with specifications definition and vendor management, or developing first-hand solutions.  Generate and execute various engineering and validation documents associated with Aprecia’s manufacturing equipment, ensuring that our pharmaceutical products are manufactured in a manner that accounts for efficiency, safety, quality, and efficacy.
 
Primary Duties and Responsibilities (Essential Functions):

1.  Participate in, and at times coordinate, activities regarding the development of automated equipment including the developing mechanical concepts and supporting drawings, definition of specifications, risk assessments, design  reviews, and test plan generation and execution
2.  Manage technology and integration vendors to ensure projects meet specifications and are delivered on time
3.  Facilitate and support product development projects through the use of software applications such as AutoCAD, SolidWorks and print controllers around Aprecia’s 3DP process
4.  Perform mechanical design and prototyping of design concepts and modifications to support 3DP process equipment and packaging equipment.
5.  Utilize technical knowledge to identify and recommend process improvements to existing equipment and systems to improve the safety, reliability and operability. Provide engineering support pertaining to process improvements, risk analysis, and troubleshooting
6.  Assist with technical investigations of non-conformance or manufacturing equipment issues.  Develop corrective and preventative actions plans to provide practical manufacturing solutions in compliance with regulatory requirements
7.  Prepare appropriate change control documentation as required for modifications to qualified equipment
8.  Assist with the preparation and review of equipment manuals, SOPs (standard operating procedures), and training 

Reporting to this Position:
No direct reports
 
Travel:
Position will require periodic travel (approximately 25%) to vendors and between Aprecia sites 
 
Work Shift:
Position typically works days but occasional support may be needed at other times
 
Knowledge, Skills and Abilities:
  • Excellent oral and written communication skills
  • Excellent data organization and presentation skills
  • Strong problem-solving and critical thinking skills
  • Ability to operate successfully in a team environment
  • Strong math skills
  • Strong interpersonal skills to participate in cross-functional teams
  • Willingness to work extended hours when required to complete projects on time
  • Knowledge of cGMP (current Good Manufacturing Practices)
 
Education and Experience:
  • B.S. degree (or higher) in Mechatronics, Mechanical, or Electrical Engineering, or equivalent required
  • 0-2 years of experience with AutoCAD and SolidWorks applications preferred.
  • 0-2 years of experience with Allen Bradley PLCs and control systems using RSView, RSLink, and FactoryTalk applications preferred.
  • 0-2 years of engineering experience, preferably in a cGMP manufacturing environment such as pharmaceutical, nutraceutical, or equivalent process-related industry required
  • Hands-on experience with three dimensional printing technologies preferred
  • Working knowledge of machine shop equipment and practices
  • Working knowledge of PC hardware, operating systems, and common industrial networks preferred
  • Working knowledge of computer systems validation lifecycle and cGMP regulations preferred
  • General knowledge of safety standards and electrical codes (NFPA, IEC) and standards desired
  • Proficiency in Excel, WORD, and PowerPoint, required; Microsoft Project preferred
 
Physical Demands and Work Environment:    
  • Ability to stand for extended periods of time within the operations areas wearing required PPE (personal protection equipment)
  • Ability to sit for extended periods of time to document and analyze testing results
  • Good manual dexterity to operate computer, general office, and engineering equipment
  • Able to clearly document specifications and other engineering needs/results
  • Fine motor skills to manage more delicate engineering movements
  • Good eyesight to read technical/instructional materials and drawings
  • Occasional odd body positions (kneeling, bending, reaching) may be required while working with engineering equipment
  • Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, etc.)
 
 
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Aprecia Pharmaceuticals Company is an equal opportunity employer. Qualified candidates are encouraged to apply for employment with us.

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