Senior Process Improvement Engineer in Bloomsbury, NJ at Volt

Date Posted: 10/17/2021

Job Snapshot

Job Description

Senior Process Improvement Engineer 

This position provides hands on support in the development and execution of products, programs and processes designed to support new product introduction and continued robustness as necessary to meet cGMP and DEA regulatory and company compliance requirements. This role will be in a leadership capacity as the primary point of contact between Quality Assurance, Compliance, Manufacturing Operations, and logistics with direct responsibilities for machine automation design, qualification and implementation at multiple manufacturing sites.  

Responsibilities may include:

  • Works collaboratively with the Vice President of Technical Operations regarding the identification and implementation of machine automation focused on driving increased control, reliability and compliance of our internal manufacturing processes
  • Partners with Quality Compliance in the development and routine implementation of quality processes required to support technical related programs (i.e. Change Control, Investigations, Master Batch Records, etc.)
  • Supports the development and execution of QuVa Pharma policies, procedures, standards, and guidelines related to technical areas (Production, Processes, New Formulation Introduction, etc.)
  • Provides hands on support in the phased introduction of process improvements required to meet Personnel and Material flow pattern objectives
  • Supports program requirements for Aseptic Operator and Process Simulation requirements
  • Provides mentorship and technical support for the execution risk-based solutions deemed necessary to address business operational and compliance challenges related to production processes
  • Oversees validation impact assessments for change controls including directing the identification and execution requirements deemed necessary to ensure quality and production robustness over time
  • Drives development and execution of Cleaning Validation and Computer Systems Validation programs

Qualifications:

  • Bachelor’s Degree in Chemistry, Biology, Pharmacy, Engineering or an appropriate science related discipline required; Or, equivalent education and relevant work experience in the Pharmaceuticals industry will be considered
  • Master’s Degree preferred
  • Minimum ten years’ experience in the manufacture, testing, and distribution of sterile Pharmaceutical/Biological products. This includes experience in site-based manufacturing and/or quality operations roles.
  • Regulatory compliance consultancy experience is a plus with regards to understanding and applying current Good Manufacturing Practices  
  • Experience at multiple sites and across multiple functions is preferred
  • Must process strong analytical and problem-solving skills, good communication skills, project management experience, extensive knowledge of GMPs, and ability to make decisions in a constantly changing environment

VOLT is an equal opportunity employer