Senior Manager, Quality Engineering

Summary

DPS Group is seeking a Manager / Sr. Manager, Quality Engineering to join our team. This position responsible for supporting the site Technical Operations (TechOps) processes related to cGMP such as Commissioning, Qualification and Validation (CQV), Computer System Configuration Management and Computer System Validation (CSV). This position ensures compliance with client's procedures and all applicable regulatory guidelines. Assisting with the commissioning and qualification of the client's manufacturing site, providing support to the site validation group tasked with implementation of new equipment and manufacturing suites. Maintaining the Validation Master Plan.

Responsibilities

• Evaluate the current status of the client's VMP, including general CQV, CSV and EMPQ to identify gaps, propose mitigation and initiate remediation.

• Work with site facility and operations teams to ensure compliance with Validation Master Plan activities.

• Support facility qualification / commissioning and operations / preventative maintenance program.

• Support and manage master equipment file.

• Implement qualification and validation life cycle for both software and equipment (IQ, OQ, PQ).

• Support the site quality system management with measurement and control strategies.

• Manage the risk assessment process for qualification and validation.

• Review technical/investigation reports as appropriate.

• Write, review, and approve proposed changes to systems and procedures, as appropriate.

• Write, review, and approve protocols and summary reports.

• Perform other duties and tasks as assigned.

• Other duties as assigned

Skills and Qualifications

• Bachelor's degree in technical discipline (Computer Science/ Industrial Engineering or similar).

• Minimum of 3 years of Quality Engineering with related experience such as Computer System Validation in a GMP environment (Drug Substance or Drug Product).

• Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10).

• Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred.

• Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product).

• Automation, equipment, and utility IQ/OQ/PQ/PV.

• Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.

• Strong knowledge of GMP, GAMP, SOPs, and quality systems.

• Experience with internal and external audit principles.

• Strong knowledge of change control practices/strategies.

• Proficient in MS Word, Excel, PowerPoint, and other applications.

• Ability to communicate and work independently with scientific/technical personnel.

• Strong communication and coordination skills, good language skills and the ability to analyze and solve problems with a positive work attitude.

• Ability to work in a dynamic, fast paced environment with shifting priorities

• Ability to work collaboratively with teams and collaborators.

• 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.