Pharmaceutical Quality Engineer Consultant
Location: Southern New Jersey
Work Arrangement: Onsite
Duration: 6–7 months
Start: Early October
Schedule: 24–40 hours per week
Travel: Local candidates preferred; qualified consultants requiring travel may also be considered
Position Overview
A pharmaceutical manufacturing organization is seeking an experienced Quality Engineer Consultant to provide temporary onsite coverage and serve as a key Quality subject matter expert during an extended leave.
The consultant will provide hands-on Quality Engineering support across commissioning, qualification, process validation, and cleaning validation activities. The role will work closely with manufacturing and engineering teams in a cleanroom environment, with particular emphasis on sterile operations, pharmaceutical water systems, and aseptic processing.
This consultant will also support technology transfer, change control, risk management, investigations, CAPA, validation strategy, and ongoing Quality Engineering initiatives while helping ensure manufacturing processes and systems remain aligned with applicable cGMP and regulatory requirements.
Key Responsibilities
- Coordinate Quality activities associated with technology and design transfer for inter-site production and external manufacturing.
- Evaluate new and existing processes against regulatory, customer, and cGMP requirements.
- Influence process design through process controls, risk-based decision-making, and proactive identification of potential Quality risks.
- Develop validation strategies in accordance with applicable regulatory and customer requirements.
- Support commissioning, equipment qualification, process validation, and cleaning validation activities.
- Collaborate with process engineers to author, review, and approve specifications, qualification protocols and reports, validation protocols and reports, and production documentation.
- Oversee and coordinate execution of qualification and validation protocols as required.
- Develop Quality plans for components and products using appropriate statistical techniques and approved inspection methods.
- Identify and implement process improvements that enhance product quality, reduce variation, and improve operational efficiency.
- Evaluate engineering change controls affecting specifications, qualified equipment, validated processes, and related systems.
- Serve as the Quality lead for root-cause investigations and implementation of corrective and preventive actions.
- Assess process risks and author or support process risk assessments.
- Provide Quality oversight for cleanroom manufacturing operations and develop a strong working understanding of production equipment and processes.
- Support Quality activities involving purified water and/or Water for Injection systems.
- Apply statistical problem-solving techniques to support timely, risk-based Quality decisions.
- Support Material Review Board activities.
- Support customer, supplier, subcontractor, and applicable regulatory or notified-body audits and inspections.
- Interface with suppliers, customers, Supply Chain, Quality Control, Quality Assurance, Production, Engineering, Analytical, and R&D personnel.
- Manage assigned projects and participate in applicable project core teams and extended teams.
- Communicate project status and significant Quality issues to management in a manner appropriate to their potential impact.
- Support additional Engineering and Quality initiatives as needed.
Required Qualifications
- Minimum of 5 years of Quality experience within a regulated pharmaceutical drug manufacturing environment.
- Strong working knowledge of FDA pharmaceutical manufacturing requirements, including 21 CFR Parts 210 and 211.
- Experience supporting commissioning, qualification, process validation, and/or cleaning validation activities.
- Experience working directly with manufacturing and engineering functions in a regulated production environment.
- Demonstrated ability to lead or support investigations, root-cause analysis, CAPA, risk assessments, and change controls.
- Ability to function as a hands-on Quality subject matter expert and provide sound, timely Quality decisions.
- Ability to work onsite in Southern New Jersey for the duration of the engagement.
Preferred Qualifications
- Experience with sterile processing and cleanroom manufacturing environments.
- Experience with purified water and/or Water for Injection systems.
- Blow-fill-seal or related aseptic processing experience.
- Knowledge of FDA aseptic processing expectations.
- Familiarity with 21 CFR Part 820 and applicable ISO standards.
- Familiarity with MasterControl.
Work Arrangement
This is an onsite consulting engagement requiring regular presence at the manufacturing site in Southern New Jersey. Local consultants are preferred, although qualified candidates who would need to travel may also be considered.
Ideal Candidate
The ideal consultant is a seasoned pharmaceutical Quality Engineer who can operate independently as an onsite Quality SME while remaining highly engaged with manufacturing and engineering teams. The strongest candidates will combine hands-on validation and Quality Engineering experience with practical knowledge of sterile manufacturing, cleanroom operations, pharmaceutical water systems, and aseptic processing.