Summary
DPS Group is seeking a Senior CQV Specialist that supports the successful implementation of laboratory and manufacturing equipment and standalone computer systems at multi-use sites through interaction with internal customers and external service providers.
Responsibilities
- The incumbent contributes to the completion of milestones associated with equipment qualification and computer systems validation.
- With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope.
- As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group and impacted business functions to achieve team goals while building trust and collaborative relationships outside the immediate organization.
- Maintains all qualified equipment and systems in compliance with approved procedures.
- Develops qualification protocols, and associated reports while adhering to a validation and change management process.
- Executes equipment qualifications and systems validation protocols.
- Supervises vendors for qualification functions.
- Develops written procedures for equipment use and administration controls, as applicable.
- Supports calibration, equipment qualification and validation activities.
- Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
- Serves as a validation SME for equipment-related investigations.
- Manages projects of limited scope and complexity within their functional area: Supports laboratory equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
- Completes qualification and validation documentation with accuracy, completeness and compliance to company standards.
- Provides excellent customer service and support: Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
- Provides technical support and guidance on calibration and equipment qualification issues.
- Interfaces with customers to ensure all expectations are being met.
- Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
Skills and Qualifications
- B.S. degree in Engineering or equivalent with minimum 5 years of experience in FDA-regulated industry, or M.S. degree in Engineering or equivalent with minimum 1 year of experience in Cell Therapy. Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
- Knowledge of 21 CFR Part 11 compliance.
- Knowledge of pharmaceutical laboratory and manufacturing systems.
- Experience generating and executing equipment qualification documents.
- Ability to interact effectively with Laboratory, Manufacturing, QA, and Facilities groups.
- Strong ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.
- Ability to effectively manage multiple tasks and activities simultaneously.
- Strong written and verbal communication skills along with solid presentation skills.
- Proficient at writing well-formulated emails and reports.
- Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
- Ability to effectively communicate with employees, contractors, and vendors.
- Experience with technical writing and document development/generation.
- Strong computer skills in Microsoft Office Suite – Word, Excel and Outlook, and the ability to learn new software as required for equipment qualification.
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.
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