Quality Engineering Consultant

Krieger Scientific; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

Krieger Scientific is seeking an experienced Quality Engineer Consultant to support a regulated pharmaceutical manufacturing operation in South Jersey. This hands-on role requires independent work within an active manufacturing environment, partnering with Quality, Manufacturing, Engineering, R&D, Supply Chain, and other technical teams.

The consultant will cover process validation, equipment qualification, CAPAs, change controls, risk assessments, technical documentation, and manufacturing

Qualifications

• Hands-on quality engineering in regulated pharma/bio/pharma environments.
• Experience authoring and executing validation protocols and reports.
• Strong CAPAs, deviations, change controls, and risk assessment expertise.
• Familiarity with FDA regulations; 21 CFR Parts 210/211; ISO 13485 a plus.
• Ability to translate regulatory requirements into practical docs.
• Excellent technical writing and communication skills.

Responsibilities

• Develop and execute validation strategies per regulatory requirements.
• Author, review, and approve equipment qualification and process validation protocols and reports.
• Lead root cause investigations and CAPA activities.
• Support change controls, risk assessments, and regulatory audits.
• Collaborate with Manufacturing, Engineering, and Quality teams to resolve issues.

Skills

Quality Engineering

GxP knowledge

Process validation

Equipment qualification

Root cause investigation

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Job description

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.
• 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.
• 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

• Sterile or aseptic manufacturing
• Cleanroom environments
• Purified water or WFI systems
• Blow fill seal manufacturing
• Container closure integrity testing

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.

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.