Manager Qualification & Validation in Bloomsbury, NJ at Volt

Date Posted: 7/15/2021

Job Snapshot

  • Employee Type:
    Direct Hire
  • Job Type:
  • Duration:
    N/A
  • Date Posted:
    7/15/2021
  • Job ID:
    278702
  • Contact Name
    Volt Branch
  • Phone
    516-228-6788

Job Description

Volt is immediately hiring a Manager Qualification & Validation to join a top company in Hunterdon County NJ.

Responsibilities:

  •  Establishes and communicates a clear vision for a fully integrated and high performing team that is aligned with the strategic objectives and business goals
  •  Ensures effective and compliance operations in accordance with site registrations, GMPS and environmental regulations and state requirements
  •  Effectively develops personnel to fully understand the ongoing requirements associated with maintaining a GMP compliant and qualified operational facility and supporting systems and sub-systems at the site
  • Defines and implements necessary improvements within the existing  operation to maintain current GMP and Industry Best practices; as well as drive industry standards with regards to 503B outsourcing manufacturing facilities through participation and engagement with regulators, industry subject-matter experts on facility operations, knowledge and principles from other related industry segments that utilize controlled environments and aseptic manufacturing
  • Stays current with industry trends and identifies opportunities for workforce development and continued education for staff
  •  Effectively executes projects that improve quality, safety, product cost, risk reduction and plant capabilities. This includes the development and preparation of required cGMP documentation required for the process and facility projects. Assures completion of all phases a project in a timely and efficient manner
  • Develops direct reports and builds a high-performance team through utilization of a performance management process that sets expectations, ensures ongoing coaching/mentoring and assesses employee performance

Qualifications:

• Bachelor’s degree in engineering or Manufacturing Management related field

• 5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry

• 3 years of supervisory or management experience required

• Project Management Certification (PMP) a plus

• Direct experience working and/or qualifying large scale mechanical systems (HVAC)

• 20,000 CFM Air Handlers

 • 20,000 CFM Exhaust Systems

• Honeywell EBI and Voltek Building Automation/Monitoring Systems • Cleanroom Design, Operation and Maintenance

 • Working knowledge of packaging systems and requirements associated with qualification and ongoing procedural requirements 

• Experience executing and managing a team specializing in pharmaceutical services (i.e. clean room certification, etc.) as well as experience in the facility and utility standards for the pharmaceutical industry is required

• Experience with pharmaceutical grade water systems and compressed air systems

Volt is an Equal Opportunity Employer