uniQure

Quality Engineer, Lead - Lexington

All jobs Print Apply
English

Job

Active since 14-09-2018 Job category Quality / Health / Environment ...
Location Lexington Level Mid-Senior level
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
uniQure is dedicated to bringing therapies for unmet medical needs to patients. Each position at uniQure is directly or indirectly responsible for improving the lives of patients. This responsibility is part of our day-to-day working life by living up to high quality standards and by recognizing the sense of urgency in areas of high unmet medical need.

Place in the Organization

The Quality Engineer Lead supports the day-to-day quality operations of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, and data integrity with a focus on quality engineering and validation aspects of biologics manufacturing production.

Key result areas (major duties, accountabilities and responsibilities):

  • Perform reviews of Validation Lifecycle documents including, but not limited to, Functional, Detailed Design, Configuration and User Requirement Specifications (FS/DDS/CS/URS) and Factory and Site Acceptance Test (FAT/SAT) protocols and Reports from a quality perspective to ensure compliance to internal requirements.
  • Perform reviews of protocols and reports relating to Facilities, Utilities, and Equipment commissioning and qualification/requalification, process/method validation, and other cGMP activities from a quality perspective to ensure compliance to internal requirements and sound technical rational.
  • Review and approve deviations and CAPAs; including performing Failure Mode Effect Analyses (risk assessments), participating in root cause analysis investigations, evaluating CAPA effectiveness, and oversight of departmental training.
  • Review and approve change controls with a focus on those pertaining to equipment, facilities, utilities and process changes ensuring validation impact, procedural impact, regulatory impact, and prescribed testing is adequate and well justified.
  • Act as a high-level technical resource to QA staff, Manufacturing and Engineering customers for interpretation of policy, review and approval of technical documents, and high-level decision making for the QA unit.
  • Represent Quality Assurance on Cross Function Team (CFT) meetings.
  • Drive and participate in continuous improvement efforts related to quality, engineering, and validation systems.
  • Mentor junior QA staff.
  • Provide inspection readiness support for third-party audits and regulatory inspections.
  • Perform internal audits and/or gap assessments as necessary.

Qualifications:

  • Bachelor’s Degree and/or Master’s Degree in Biology, Chemistry, Microbiology, Chemical Engineering or related technical field
  • Quality Assurance experience and/or technical background
  • 10+ years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
  • Well versed in cGMP/ICH/FDA/EU regulations and guidelines]
  • Knowledge of process validation requirements
  • Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)
  • Position requires incumbent to be capable of lifting 25 pounds and must be able to demonstrate ability to gown aseptically
  • Internal and/or External audit experience preferred

Core Competencies:

  • Strong written and verbal communication skills
  • Strong organizational skills
  • Team player and the ability to influence others and work well with diverse groups
  • Self-motivated
  • Detail oriented
  • Good problem solving skills
  • Ability to multi-task in a fast-paced environment with changing priorities
More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region United States
Keywords Quality Engineer

Contact information

Name Jennifer Wagner

Location

Apply