Quality Engineer Consultant
Krieger Scientific
Location: South Jersey, NJ
Consulting Engagement
Position Overview
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
• MasterControl
• 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 independentlyevaluate 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 Quality and compliance decisions.
About Krieger Scientific
Krieger Scientific provides engineering, commissioning, qualification and validation, calibration,
asset management, relocation services, quality and compliance consulting, and technical
staffing solutions to pharmaceutical, biotechnology, and medical device companies.
Equal Employment Opportunity
Krieger Scientific is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all
applicants and employees. Employment decisions are based on qualifications, merit, business needs, and performance without
regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran
status, or any other characteristic protected by applicable federal, state, or local law.