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Senior Project Manager, Engineering

Company: Aircall
Location: Columbus
Posted on: April 8, 2021

Job Description:

Andelyn Biosciences is an industry leading cGMP productionfacility dedicated to advancing the field of gene therapy. Our mission is touse our knowledge, resources, technology, and experience in the field oftranslational and regulatory science, to develop new, safe, and effectivelong-term treatments for diseases. There is no disease too rare and nochallenge too difficult as we strive to make a difference with every productand to leave hope on the minds of every patient and their families. Andelyn is primarilya full-service manufacturer of Adeno Associated Virus (AAV). We work withover 100 clients each year to manufacture AAV at development, toxicology,clinical and commercial quality. The--Senior Project Manager, Engineering--isaccountable for facility design/build, construction project management and theharmonization of facility engineering systems and maintenance and Health,Safety and Environmental procedures and practice to assure proper officeaccommodation, cleanroom manufacturing space, warehousing and a safe workenvironment in compliance with all state, federal, and regulatory governingagencies. Principal Duties and Responsibilities

  • Harmonized facility maintenance procedures and practices tocover critical systems such as HVAC, sanitization, security, safety program,metrology, preventative/predictive maintenance program, contract services,environmental permitting, critical facility documentation, space planning,facility asset management (excluding IT related assets), building and maintenancemonitoring systems in compliance with local and federal regulatory authoritiessuch as: OSHA, state permits, FDA, EMA, etc.
  • Continuous improvement program to review opportunities toassure that facility maintenance, safety and environmental related systems andprocedures across all sites run in an efficient, cost effective and compliantmanner.
  • Construction project management for a biologic manufacturingand filling facility design/construction/qualification performed on time and onbudget.
  • Engineering consultation on new facility projects at allsites.
  • Manages all project administration efforts, to includecontract(s), budget management and consultant procurement for servicedocuments.
  • Responsible for space planning and allocation to optimizebuilding space and layout for current and future needs; coordinate officemoves, including distribution of furniture and workspace modifications
  • Monitor and coordinate the work of outside contractorsincluding general contractors, architects, engineers, and material andequipment suppliers
  • Define, plan, and manage the full scope of assignedprojects.
  • Forecast, track, and manage project budgets, POs, andinvoices in accordance with generally accepted accounting principles
  • Coordinate appropriate internal and external resources(technical & non-technical) to meet project needs
  • Coordinate project commissioning, qualification, andvalidation (CQV) efforts
  • Review drawings and specification for accuracy andconsistency with existing standards
  • Environmental permitting at all sites up to date and currentas required by state and federal authorities
  • Safety program that meets OSHA and state requirements toassure a safe work environment for all employees.
  • GMP compliant metrology process for all equipment andinstrumentation.
  • As built drawings and process flow diagrams - maintained inan up to date status and readily retrievable
  • Performance metrics for Facility and HSE systems/programs
  • Emergency response plan
  • A safe work environment for department employees.
  • Annual proposed expense and capital budget for theEngineering/HSE department.
  • Department staff compliance with corporate and site-specificHR, safety and business policies and practice.
  • Job specific curriculum for the training and professionaldevelopment of department staff. Knowledge, skills, and abilities required
    • Bachelor's Degree and/or equivalent combination of relevanteducation and experience will be considered.
    • 10 years of related experience and/or training inEngineering or related field required
    • Experience in new construction andqualification/commissioning of a new facility or expansion
    • Strong project management and organizational skills.
    • Extensive cleanroom, packaging/filling & Isolatorqualification, and operation experience.
    • Experience working in an FDA/EU/RoW regulated manufacturingfacility preferably in sterile injectables
    • Expert computer applications skills (Excel, Word, Visio, andPP).
    • Excellent team facilitation, communication and influencingskills.
    • Excellent documented leadership skills and navigate in afast paced environment.
    • Demonstrated ability to assign priorities in a fast-pacedand changing environment Minimum Physical Requirements
      • Sitting for extended periods Constantly (67-100%)
      • Talking on the phone/in person Constantly (67-100%)
      • Typing on a computer keyboard Constantly (67-100%)

Keywords: Aircall, Bloomington , Senior Project Manager, Engineering, Executive , Columbus, Indiana

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