C&q Manager

3 weeks ago

Gaithersburg, United States DPS Group Full time

Summary DPS Group is seeking an Commissioning & Qualification (C&Q) Manager for one of our top-tier pharmaceutical clients. This position will be reporting to the Project Manager and is a key member of the project management team. The C&Q Manager works closely with contractors and their sub-contractors during commissioning and qualification phase to ensure safe and successful project delivery by overseeing their delivery approach, management and deliverables are executed as per approved project VMP, VP and other associated project procedures.

Location: Gaithersburg, Maryland, United States

Employment Type: Full-Time

Reference Code: TSO824611NJ

Date Posted: 12/Apr/2024

Years of Experience Req.: 0 Years

**Summary**
DPS Group is seeking an Commissioning & Qualification (C&Q) Manager for one of our top-tier pharmaceutical clients. This position will be reporting to the Project Manager and is a key member of the project management team. The C&Q Manager works closely with contractors and their sub-contractors during commissioning and qualification phase to ensure safe and successful project delivery by overseeing their delivery approach, management and deliverables are executed as per approved project VMP, VP and other associated project procedures.

**Responsibilities**
- Assist the Project Manager (PM) to establish appropriate C&Q stage strategy, scheduling and resources plans required for Stage 2 and Stage 3 deliverables
- Support the PM to manage the relationship of Customer stakeholders especially Site Quality for GMP compliance and Customer Rep team responsible for operational readiness
- Ensure that project VMP is established and approved for use (which may include writing as agreed with Site Quality)
- Develop C&Q Plan in accordance with the project VMP and oversee the completion of C&Q planning assessment - SIA, Risk Assessments, Vendor Assessment and others as per C&Q procedures;
- Work closely with Construction Manager to ensure seamless transition of systems from MC to start-up.
- Oversee and management the completion of project C&Q documentation such as protocols in a timely manner;
- Oversee execution of “Safe to Start” review before system energization;
- Oversee and manage “live system” operations during C&Q phase if system is still under project team care and custody including management of “live system” status board;
- Support implementation of the “Client SHE Requirements” with Project Construction SHE Manager focusing on risks during start-up, commissioning and qualification phase. Support use of Reporting and Observation PM-Vitals;
- Lead and manage C&Q/CSV resources (personnel, documentation, test equipment) to ensure successful execution of C&Q/CSV within project schedule and budget;
- Ensure that appropriate training for C&Q resources are completed for their role;
- Approval and acceptance of systems and construction Turnover Packages at Mechanical Completion;
- Oversight and Governance that commissioning and qualification protocol results, raw data calculations, and completed test scripts have met established acceptance criteria and been reviewed to standards, processes and procedures;
- Review and oversight of FAT and SAT events and documentation. Approval and acceptance of equipment at SAT completion;
- Oversee and manage system calibration and tuning during C&Q phase in a

Report C&Q progress to PM to be incorporate into monthly Project Progress Report;
- Develops and maintains a commissioning and qualification PDR Board of system energization, commissioning and qualification activities;
- Lead and manage deviation closeout process during C&Q phase;
- Plan & manage system handover post successful commissioning and/ or qualification to Customer Rep team;
- Acceptance of A0, A1, A2, and A3 Certificates and provide the Go/No C&Q Stage check points progression;
- Support Project Manager to obtain H1 certificate signoff with Customer Representative team. Identify and review with team best practices and lessons learned from past projects within and external to client.
- Other duties as assigned

**Skills and Qualifications**
- Preferred to have a Mechanical background

**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.

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