Summary
DPS Group is seeking a Senior Quality Engineer that will be responsible for the quality aspects of design, installation, commissioning start up and validation of manufacturing systems, processes, products and facilities at the client site in Coppell, TX.
Responsibilities
•
Ethical conduct and compliance
•
Identify potential sources of variation in materials, processes, facilities, equipment, and products that may impact consistent performance or product quality
•
Evaluate equipment and processes and identify potential critical parameters based upon possible impact on product quality attributes
•
Prepare and perform qualification, requalification, and process validation protocols, analyze collected data against pre-determined criteria, and prepare final reports in compliance with relevant regulations, industry practices, and policies and procedures
•
Perform and document field verification of equipment, instruments, and facilities as required by approved protocols
•
Perform and/or review risk assessments for instruments, equipment, processes, and products
•
Analyze data and information to determine whether processes, equipment, and products are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis
•
Prepare, document, and/or evaluate change controls to ensure that equipment, products, processes, and facilities remain in qualified, validated state
•
Identify and investigate unusual or unexpected events, data, or sources of variation during the development and performance of qualifications/validations; assess and recommend disposition regarding the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions
•
Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP
•
Other responsibilities as assigned by department management
•
Other duties as assigned
Skills and Qualifications
•
Bachelor’s degree in a science, technical or engineering field
•
At least 5 years of experience in pharmaceutical or related industry
•
Demonstrated understanding of process design, qualification and validation concepts including the capability to assess processes, equipment and products for sources of variation
•
Ability to analyze data against predefined criteria and reach appropriate conclusions
•
Must have attention to detail.
•
Work requires a high degree of accuracy in complex documentation
•
Must understand concepts of qualification and validation as well as sampling, risk evaluation, and detection of variation
•
Able to work cooperatively with other members of the Validation Team, Quality, and Manufacturing in the design and performance of qualification and validations
•
Must effectively evaluate information collected from various sources and determine impact upon controlled state of processes, equipment, facilities, and products
•
Excellent technical writing and verbal communication skills
•
Requires the ability to apply scientific and analytical principles for solving problems and proper design of qualifications and validations
•
Working knowledge of cGMP and other applicable guidelines and regulations
•
Awareness of qualification of control systems and computer system validation (CSV)
•
Knowledge of and ability to read P&IDs and other technical information and incorporate into user, facility, and equipment specifications
•
Performs other duties as assigned by management.
•
Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
Additional
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•
Continuous Learning –Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
•
Culture – Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
•
Customer Services – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
•
Planning and Organizing – Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.
•
Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others’ views. Gives and welcomes feedback. Puts success of team above own interests.
•
Use of Technology – Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
•
Language Ability – Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
•
Mathematical Ability – Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
•
Reasoning Ability – Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.
The Company
DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.