Staff Quality Engineer
Summary/Objective Under minimal supervision, the Staff Engineer provides validation expertise and supervision of multiple complex activities for process, equipment, and/or computer validation associated with our company's systems and services. Designs, implements, and documents validation for manufacturing equipment, utility systems, facilities, and manufacturing processes. Coordinates the implementation of interdepartmental process validation programs. Performs activities across key quality functions to support the business units. Supervises and/or leads lower-level staff as assigned.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Serves as a principal technical expert in regard to validation activities associated with equipment, computers, and processes. Serves as the validation expert for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes, and computer/information/automation validation.
- Leads multiple complex validation activities associated with computers, equipment, and processes.
- Performs validation functions to ensure accurate and timely completion with frequent decision making, coordination and communications required. Creates, reviews, approves, tracks, and presents documents and procedures required for compliance with regulations.
- Plans and establishes technical communications, document flow, testing requirements, and resources necessary to complete the validation of a system.
- Prepares, reviews and approves production, validation, audit reports, risk assessments, and/or master batch record documents, procedures, and rationales.
- Leads manufacturing investigations and CAPA activities, risk and impact assessments, and provides conclusions.
- Identifies areas of non-compliance reviews recommendations of others, and implement solutions to resolve major quality and productivity issues.
- Coordinates validation associated audit activities; establish rationales and technical defense positions.
- Conveys the validation requirements for projects with customers. Resolves significant validation, product, and regulatory issues as it pertains to client projects.
- Prepares and conducts quality systems trainings and required GMP trainings across the company, as assigned.
- Lead optimization of manufacturing processes, time studies, and input into quotation processes.
- Supports systems and new product introduction by serving as a technical resource, providing technical expertise, problem-solving, and strategies for problem prevention.
- Participates as the validation representative in project team activities and process design to ensure cGMP compliance and interdepartmental consistency within the validation program.
- Leads the equipment life cycle including interacting with machine builders, drafting and reviewing user requirements and functional design specifications (URS and FDS), factory and site acceptance testing (FAT/SAT), writing and executing Installation, Operational, Performance Qualification Protocols (IQ/OQ/PQ).
- Performs process validations and process trend analyses as needed for customer projects.
- Assures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.
- Maintains current knowledge and serve as a technical resource for emerging trends and technologies.
ADDITIONAL POSITION REQUIREMENTS
- Assists in Compliance activities, internal and external audits as well as FDA Pre-Approval Inspection programs.
- Coordinates and provides training and/or opportunities for the career development of others. Identifies training needs and assists develop training programs.
- Carries out duties in compliance with all federal and state regulations and guidelines.
- Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions.
- Remains current in profession and industry trends.
- Makes a positive contribution as demonstrated by:
- making suggestions for improvement
- learning new skills, procedures, and processes.
- Is available for other duties as required.
- Is available for overtime as needed.
Mentor and/or supervise lower-level staff as assigned.
QUALIFICATIONS: EDUCATION and/or EXPERIENCE
Bachelor's Degree in a scientific field or Engineering is required and eight (8) years of experience in Pharmaceutical or Medical Device Development/Manufacturing or a Master's of Science in a scientific field or Engineering with at least five (5) years of equivalent experience.
- Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions, and specifications.
- Legible Handwriting
- Communicate clearly in writing and orally.
- Work with mathematical concepts such as regression analysis, design of experiment (DOE), statistical quality control (SQC), capability analysis, probability, and statistical analysis.
- Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios, and proportions to practical solutions.
OTHER SKILLS, ABILITIES, OR QUALIFICATIONS
- Scientific understanding: Process Development and Engineering, Formulation Development, Basic Chemistry and Physics, Quality by Design, Technical Transfer and Process Validation
- Validation experience is a plus
- Demonstrate understanding of various root cause analysis techniques such as 5 why's, FMEA, Fishbone diagraming, and fault tree analysis.
- Familiarity with Quality by Design or other structured design and process
- Demonstrate effective collaboration and teamwork.
- Demonstrate experience working in a cGxP environment.
- Successfully completes regulatory and job training requirements.
- Computer skills:
- Enter data into computer Using software applications for data entry and word processing.
- Work and be proficient with e-mail systems
- Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
- Ability to work with others in a team environment.
- While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
- The employee is occasionally required to sit and reach with hands and arms.
- The employee must be able to lift and/or move up to 50 pounds frequently.
- The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- Travel will be required less than 10% of the time, domestic and international