Quality Engineer (6-Month Consultant)

Position Details:

• Company: Keystone Industries

• Please visit our website at www.keystoneind.com to learn more about Keystone Industries and career opportunities.

• Title: Quality Engineer/Consultant

• Schedule: Approximately 40 hours per week on average; actual hours may fluctuate, and some weeks may require fewer hours.

• Location: Gibbstown, NJ (08027) - on-site requirement.

• Ideal Candidate: The ideal candidate will have 5-10 years of related experience. Experience with pharmaceutical and medical device production processes is required. Candidates should have experience with aseptic processing, including equipment qualification, process validation, and SOP authoring and implementation. Experience working in GMP-regulated manufacturing environments is strongly preferred.

• Salary/Pay Range (based on experience and qualifications): $75-$125 per hour, commensurate with experience and qualifications. Rate is flexible for highly qualified candidates.

• Consulting Engagement: We are seeking a consultant for an approximately six-month engagement to serve as a temporary backfill. This position will be structured as a 1099 independent contractor arrangement, and the selected consultant will be responsible for providing all required documentation and meeting applicable compliance requirements.

Essential Job Functions:

• Coordinate applicable steps to verify appropriate technology/design transfer for inter-site production and/or toll manufacturing.
• Evaluate new processes against regulatory, customer, and cGMP requirement. Influence process design by implementing process control techniques and risk-based decision making proactively, anticipating potential risks and recommending improvements.
• Develop validation strategies in accordance with regulations and customer requirements, applying judgment to resolve complex situations.
• Develop quality plans for components and products by applying statistical techniques and approved inspection methods.
• Identify and implement process improvements to enhance product quality, reduce variation, and increase operational efficiency.
• Develop quality plans for components and products by applying statistical techniques and approved inspection methods.
• Collaborate with process engineers to author, review, and approve specifications, equipment qualifications and process validation protocols and reports, and production documentation. Oversee and coordinate protocol execution as required.
• Evaluate engineering change controls, including but not limited to changes to specifications, qualified equipment, and validated processes.
• Act as quality lead for root cause analysis investigation and corrective/preventative action implementation.
• Assess process risk and author process risk assessments.
• Manage projects and participate in applicable project core team(s) and extended team(s).
• Interface regularly with external suppliers and customers, supply chain, quality control, quality assurance, production, engineering, analytical and R&D personnel.
• Works closely with production in a cleanroom environment to establish an understanding of production equipment and processes
• Provide sound and timely decision-making utilizing statistical problem-solving tools.
• Support Material Review Board (MRB) efforts.
• Support notified body, customer, supplier, and subcontractor audits and inspections.
• Keep management informed on project status and significant quality issues in a manner commensurate with the potential impact of the issue.
• Support future Engineering and Quality initiatives.
• Perform research as needed to support other job functions and responsibilities.
• Perform additional duties/tasks as needed or requested by management.

Qualifications:

• A minimum of 5 years of experience in Quality in a regulated pharmaceutical drug manufacturing environment is required. Experience working in sterile processing and cleanrooms preferred.
• Understanding of QMS, GxP and FDA CFR requirements
• Ability to apply principles of root cause analysis and statistical analysis to determine common vs. special causes is required. Ability to develop and implement CAPA plans and apply concepts leading to improvements in quality processes is required.
• Strong understanding of design control process including design validation/verification, process validation and design transfer.
• Demonstrated project management skills. Ability to successfully work on multiple projects simultaneously.
• Ability to independently design experiments for troubleshooting.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, graphs, charts, diagrams). Ability to deal with a variety of abstract and concrete variables. Ability to interpret information furnished in written, oral, or diagram form.
• Mechanical aptitude - good understanding of mechanical equipment in a manufacturing environment
• Provides guidance to Quality Engineering team
• Ability to work in a team-based environment and work collaboratively to solve problems.
• Self-starter, strong initiative, dependable and capable of following through with minimal supervision.
• Proven ability to perform under deadlines, to adjust plans to meet changing needs and requirements.
• Excellent oral, written, listening, and presentation skills and ability to clearly articulate complex information to others.
• Excellent attention to detail and organizational skills.
• Good interpersonal skills.
• Computer proficiency including Microsoft Office Suite.
• Problem solving and critical thinking skills.
• Strong technical writing skills.

Desired Skills:

• Understanding of 21 CFR 210, 211, 820 and FDA Aseptic Processing Guidelines.
• Experience working in sterile processing and cleanroom environments. Experience with purified and/or WFI water systems.
• Extrusion or blow-fill-seal experience.
• Container-closure integrity testing.

Education/Certifications:

• Bachelors degree is required. A Chemical Engineering degree is preferred, but a degree in Engineering, Life Science, Physical Science or a related field will be considered.
• LEAN/Six-Sigma Training/Experience/Certification preferred, QE certification, or advanced degree a plus.

Safety:

• Comply with all safety regulations; maintains a safe work environment at all times.
• Adhere to always wearing the proper PPE/Safety equipment.
• Understand and comply with all written safety, health, and environmental procedures.
• Attend all required scheduled Health, Safety and Environmental training sessions.
• Participate in required Health, Safety and Environmental initiatives and programs.
• Perform required administrative functions related to Health, Safety and Environmental functions such as completing forms, checklists, and log sheets.

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Physical Demands: Employee is required to walk; stand; sit; use hands and fingers to manipulate objects, tools, or controls; reach with hands and arms to operate a computer and other office equipment, and occasionally lift/move up to 25 lbs. Minimal need to balance, stoop, bend, kneel or climb.
• Work Environment: This position is located in an office setting, within a manufacturing facility. Noise intensity level: quiet to low. Employees may occasionally need to enter manufacturing or lab areas, including cleanroom environments, which may include exposure to moderate noise, moving equipment, and hazardous contaminants. When entering these areas, employees must adhere to all applicable safety protocols, including Personal Protective Equipment (PPE) and/or gowning requirements. Occasional travel may be required for audits, inspections, site visits, customer meetings or events, and industry conferences.