Quality Engineering Consultant

Quality Engineer Consultant

Krieger Scientific has an opportunity for an experienced Quality Engineer Consultant to support a regulated pharmaceutical manufacturing operation in South Jersey.

This is a hands on Quality Engineering role for someone who can work independently within an active manufacturing environment and partner closely with Quality, Manufacturing, Engineering, R&D, Supply Chain, and other technical teams.

The Quality Engineer Consultant will support process validation, equipment qualification, quality investigations, CAPAs, change controls, risk assessments, technical documentation, and manufacturing troubleshooting. The role requires someone who can understand both the technical and regulatory requirements of a process, ask the right questions, and translate those requirements into clear, compliant execution level documentation.

The initial engagement is expected to run approximately six months with an anticipated October start. As Krieger Scientific continues to grow, this engagement may lead to additional opportunities within the organization.

Key Responsibilities:

• Develop and execute validation strategies in accordance with applicable regulatory and customer requirements.
• Author, review, and approve equipment qualification and process validation protocols and reports.
• Define appropriate test cases, acceptance criteria, and validation requirements.
• Coordinate and support protocol execution within the manufacturing environment.
• Evaluate new and modified manufacturing processes against regulatory, customer, and cGMP requirements.
• Support technology transfer and design transfer activities for new or modified products and manufacturing processes.
• Evaluate engineering change controls involving specifications, equipment, processes, and validated systems.
• Lead and support root cause investigations and CAPA activities.
• Author and support process risk assessments.
• Apply statistical and risk based approaches to manufacturing and Quality issues.
• Identify process improvements that enhance product quality, reduce variation, and improve operational efficiency.
• Work directly with Manufacturing and Engineering to troubleshoot Quality and process issues.
• Author, review, and revise SOPs, specifications, production documentation, validation documentation, and other Quality records.
• Support Material Review Board activities as required.
• Provide Quality direction and technical guidance to cross functional team members.
• Support customer, supplier, regulatory, and other applicable audits and inspections.
• Identify gaps within existing Quality processes and help develop compliant, practical solutions.
• Manage multiple priorities and projects within a fast moving manufacturing environment.

Qualifications:

• Quality Engineering experience within a regulated pharmaceutical, biotechnology, combination product, or medical device manufacturing environment.
• Strong pharmaceutical manufacturing and cGMP experience preferred.
• Recent hands on experience with process validation and equipment qualification.
• Experience authoring and executing validation protocols and reports.
• Experience with CAPAs, deviations, nonconformances, change controls, root cause investigations, and risk assessments.
• Understanding of QMS, GxP, and applicable FDA requirements.
• Working knowledge of 21 CFR Parts 210 and 211. Experience with 21 CFR Part 820 and ISO 13485 is a plus.
• Ability to translate regulatory and technical requirements into practical execution level documentation.
• Strong technical writing skills.
• Experience working directly with Manufacturing and Engineering teams in a production environment.
• Ability to independently troubleshoot manufacturing and Quality issues.
• Ability to make sound Quality decisions with limited supervision.
• Strong communication skills and the ability to effectively support Quality requirements across different functional groups.
• Ability to adapt to changing priorities and operate effectively in an evolving manufacturing environment.
• Bachelor's degree in Engineering, Life Science, Physical Science, or a related technical discipline. Chemical Engineering or a related engineering discipline is preferred.

Preferred Experience:

• Master Control
• Sterile or aseptic manufacturing
• Cleanroom environments
• Purified water or WFI systems
• Extrusion
• Blow fill seal manufacturing
• Container closure integrity testing
• Combination products
• LEAN or Six Sigma training or certification

What Success Looks Like:

The successful consultant will be comfortable moving between technical Quality Engineering work and hands on manufacturing support. This person should be able to independently evaluate a process, identify Quality or compliance gaps, determine what documentation or validation work is required, and work collaboratively with technical teams to develop and implement an appropriate solution.

This role is best suited for someone who remains close to the work and is comfortable writing documentation, executing protocols, troubleshooting on the manufacturing floor, and standing behind sound…