Supplier Quality-Engineering Support

ADVENT Engineering, a Trinity Consultants Company, is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered in Dallas, TX with operations in the Eastern US and Canada, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of Compliance Specialists involved in the creation, tracking, and closure of CAPAs associated with facilities maintenance. Forming and working within cross functional teams is considered an asset.

A combination of strong technical aptitude, preventative maintenance experience, and data analysis are the desired skill set.

This is an outstanding opportunity to join our growing team!

Qualifications: Bachelor’s Degree/Undergraduate degree in Engineering, Biology, or equivalent. At least 5 years of related work experience in a QA or Compliance setting.

Requirements: Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to implement Corrective and Preventative Actions

Manages and participates in Facilities Department CAPA Program. Ensures that all activities related to CAPAs are performed in a timely manner and in compliance with procedures and regulatory requirements.

Daily monitoring and tracking of CAPAs assigned to the facilities department.

Responsible for all aspects of CAPA ownership including facilitation of cross functional meetings with relevant stakeholders, completion of extension requests where applicable, and submission of evidence to QA.

Initiation and ownership of requests and workflows in Computerized Maintenance Management System (BMRAM)

Attend Weekly Meetings to discuss CAPA progress and escalation of obstacles, including presenting, taking notes, managing agenda items and invites.

Ownership of CAPA Effectiveness Checks including the review and analyzing of relevant data and completing reports documenting findings

Provides support and training for Facilities personnel on regulatory and quality topics, such as proper documentation procedures and the use of QUMAS.

Key responsibilities: Well-developed communication skills, both verbal and written.

Outstanding Organization skills (required to handle multiple projects concurrently)

Strong data analysis skills (excel, performance metrics).

Strong GMP background including working knowledge of preventative maintenance principles.

Familiar with a broad range of equipment used in pharmaceutical production, including but not limited to: bioreactors, chromatography skids, centrifuges/separators, air handlers, HEPA.

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