GMP Facilities Engineer

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Durham, United States Medasource Full time

Summary

This position is responsible for assisting the Business Operations Lead to develop, implement, and oversee equipment and facility maintenance management for cGMP manufacturing facility deliverables. Additionally, this position will develop/deploy/maintain standard work and systems for proactive predictive key performance indicators to prevent equipment/facility disruptions in support of early phase cGMP manufacture of materials for candidate vaccines. This position will lead all aspects of cGMP facility and equipment maintenance required to support a large portfolio of products.


Responsibilities

  • Collaborates closely with Operations/Quality/Analytical Development/Process Development/Quality Control/Portfolio management teams to provide support for cGMP manufacturing activities and works to learn the technical details of the cGMP facilities equipment, maintenance, and systems.
  • Maintains all equipment and facilities required for cGMP production, including working with vendors to meet CLIENT maintenance/budgetary/documentation needs, performs investigations which include authorship of detailed reports, compiling trends/risks/and recommendations to wider cGMP team/Quality, supporting the alarm management committee and negotiates contracts and pricing. This includes developing, deploying, and maintaining systems to manage equipment/facility portfolios for all cGMP spaces (manufacturing, support, and analytical).
  • Maintains cGMP equipment and facilities on a daily/weekly/monthly/quarterly basis, including working with vendors to meet CLIENT calibration/repair/documentation needs; executes cGMP activities such as cleanroom cleaning and certifications; performs investigations; and negotiates pricing.
  • Designs facility maintenance workflows, executes and documents cGMP activities in compliance with regulatory requirements. Performs routine reporting of the state of the business to internal stakeholders (weekly facility schedules / shutdown plans / alarm trends, etc) and collaborates with Quality to deliver on facility related change controls.
  • Leads and manages winter and summer shutdowns for cGMP facilities, inclusive of quote negotiation, purchase order submission, scheduling with vendors, oversight of execution, and close-out of records. Provides start-up and on-going task execution, including commissioning / qualification / protocol documentation ownership and support, for cGMP facilities for equipment and systems items, such as processing equipment, critical utilities, and facility infrastructure. Manages timelines and all deliverables included in this scope, such as SOP authorship, qualification requirements, tracking of issues/resolution, and turnover change control documentation closure.
  • Writes and reviews scopes of work; writes protocols for equipment validation and operation/ system validation and SOPs for cGMP systems including presenting data to project teams and external stakeholders. Participates in facility audit readiness, hosts tours, and maintains a state of compliance for all facilities / systems / equipment at all times.
  • Compiles trend data, performs analysis / interpretation, and draws conclusions regarding progress of work, utilizing the data in appropriate decision making; summarizes data, presents results and proposes next steps to advance the cGMP program.
  • Performs root cause analysis for all investigations and implements robust corrective actions in a timely manner. Uses good documentation practices for all records, adhering to SOPs, and performing self-audits to ensure compliance. Trains the broader cGMP team and vendors on proper equipment/facility management practices and acceptable corrective actions for a cGMP compliant organization.
  • Performs other related duties as necessary and requested by GMP leadership.


Work hours

You must be willing and available to work flexible hours which may include later start and end times with the understanding that work hours may need to be extended until a project/task has reached a logical and acceptable stopping point to maintain the integrity of the process.


Education, Skills, & Experience Requirements

  • Education: Bachelor's degree in a science, engineering, or related field. A Master's degree is preferred.
  • Experience: 4 years relevant experience in the biopharmaceutical industry or equivalent.

Preferred Experience:

Preferred experience that include the following:

  • Experience with facility and equipment maintenance planning
  • Hands-on maintenance experience with the execution of maintenance duties
  • cGMP Vaccine and/or Biologics manufacturing experience (clinical manufacturing and/or licensed product manufacturing)
  • Experience with cGMP manufacturing (clinical manufacturing and/or licensed product manufacturing)
  • Solid understanding of cGMP facility regulations for Vaccines and/or Biologics
  • Direct experience working with third-party vendors
  • cGMP Facility and/or equipment start-up experience
  • Master’s degree is a plus

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