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Quality Engineer

3 months ago

Lenoir, United States Exela Pharma Sciences Full time
Position Summary:

The Quality Engineer will be responsible for providing Quality oversight to the engineering functions at the Company. In this role they assure the company’s Quality Plan is fully implemented by the engineering department for operations, maintenance, and project delivery. The Quality Engineer will assure that cGMPs and regulatory standards are applied in a consistent manner by the implementation of processes, methods, and procedures. They will routinely participate in quality decisions involving engineering activities and audit engineering practices to assure compliance with expectations.

Job Responsibilities:

The Quality Engineer will be responsible for the following areas
  • Change Management – Assure that the engineering department adheres to regulatory, and company change management requirements. Possess strong Change Management knowledge.
  • Asset Management – Provide support to maintenance department and assure proper calibration/PMs/PdM etc. are conducted of critical instruments and equipment
  • Project Management – Assure adherence to GMP requirements in the design, construction, procurement, commissioning, qualification and validation of new facilities and assets.
  • C&Q and Validation – Provide Quality support and oversight for commissioning, qualification and validation of new and existing processes.
  • Quality by Design (QbD) – Participate in QbD activities with engineering to increase process capability, reduce product variability and defects by enhancing process design, understanding and control.
  • Requirements Definition – Participate in the definition of User Requirements and make sure they conform with regulatory guidance
  • Critical Process Parameter (CPP) Definition - Assure CPPs are defined and understood by engineering and incorporated into design and control functions
  • Training Requirements – Establish and deliver GMP training requirements for engineering and maintenance staff.
  • Periodic Quality Assessments – participate as required in Periodic Quality Assessments of operations and asset management.
  • Risk Management – Assure Risk Management decisions are done in a disciplined manner to document decisions and rationale.
  • Data Integrity – Assure any GMP data captured and managed by engineering is stored and maintained in a compliant CSV manner.
Required Skills:
  • Expertise in Pharmaceutical Processes, manufacturing operations, and technical engineering skills
  • Depth of knowledge with regards to cGMP requirements and compliance
  • Demonstrated understanding of Risk Management principles and practices
  • Understanding of Quality by Design approach
  • Strong competency in C&Q/CSV/GAMP and Validation practices.
  • Proficient in writing and editing documents
  • Strong written and oral communication skills.
  • Ability to work in a team environment.
  • Facilitate issue resolution – Address quality issues and work to successful resolution
  • Attention to Detail – ability and willingness to dig into details.
  • Independent worker – Self-starter - ability to work independently with minimal day–to-day direction.
Education and Experience Requirements:
  • B.S. Engineering- Mechanical, Chemical, or similar – Required
  • Background in Quality Management – Strongly Desired
  • Minimum of 4-5 years’ experience working in GMP manufacturing and/or engineering environment. - Required
  • Proficient in the use of Word, Excel, PowerPoint, and other Office suite software – Required

EOE, including disability/vets.