Wunderlich-Malec Engineering (WM) is a 100% employee-owned ESOP and one of the largest and most well-established engineering companies in the United States. When you join WM you become part of a company that is:

We have a Senior Project Manager Opportunity in Norton, MA. This person will be responsible for overseeing the Commissioning, Qualification, and Validation (CQV) phases of a South Shore Expansion project.

YOU

When you become part of Wunderlich-Malec you:

Are a 100% employee-owner
Work with Fortune 500 clients
Are part of an ENR (Engineering News Record) Top 500 firm

Right away you will notice the small company feel of Wunderlich-Malec with a strong focus on people.

Empowered Individuals - Employee owned, we hire the best and empower them to develop and deliver solutions.

Rewarded & Motivated - Investing in continuing education and world-class benefits keeps our staff motivated.

Positive Attitudes - Dedicated experts are committed in the long-run and bring a positive, can-do attitude to your project.

Knowledgeable - Recognized industry experts reinforced with ongoing training remain knowledgeable on the latest industry trends and directions.

The Project overview

The scope of this project is to fit out the Train 2 Commercial Manufacturing Shell and support areas on the South Shore site to support commercial manufacturing. This role will be involved from design through GMP release of the facility.

The Job Overview

As the CQV Project Manager, you will be responsible for overseeing the Commissioning, Qualification, and Validation (CQV) phases of the South Shore Expansion project. This role will involve collaboration with client technical and operational leads, interfacing with construction management partner, and managing aspects of the CQV process to ensure that the facility, systems, and equipment meet all regulatory requirements, industry standards, and the specific needs of the project.

You will work closely with various stakeholders including internal teams, contractors, vendors, and quality assurance teams. The goal is to ensure that the facility is fully compliant with all applicable guidelines, and that the CQV processes are executed effectively, efficiently and within schedule and budget.

Key Responsibilities

CQV Strategy & Planning:
- Partner with Validation and Engineering to develop and implement the overall CQV strategy for the project, including timelines, resources, budget management, and risk management plans
- Prepare and execute Plans (including Commissioning, Validation, and others as needed for project), ensuring alignment with project goals, Client procedures, and regulatory expectations
- Develop and maintain a detailed schedule for equipment and facility commissioning, qualification, and validation activities from design through GMP release of the facility
- Engage with Construction Manager to define and understand construction start-up activities, and ensure completion prior to start of CQV
- Collaborate with internal teams and external contractors to ensure all systems and equipment are prepared for qualification and validation activities
Team Leadership & Coordination:
- Lead the CQV project team, including engineers, contractors, and vendors, to ensure smooth execution of start-up, commissioning and qualification activities
- Lead the team in startup of equipment in a safe and effective manner; as well as performing risk assessments and impact assessments
- Act as the main point of contact for all CQV-related issues, facilitating collaboration both within the project team and with Client
- Ensure effective communication and collaboration between the CQV team, project management, engineering, and quality assurance teams
Compliance:
- Ensure compliance with all relevant industry regulations, including FDA, EMA, and other applicable guidelines, during the commissioning, qualification, and validation phases
- Ensure that all CQV documentation, including protocols, reports, and change control documents, meet Client SOPs and are completed in a timely manner
Risk Management & Issue Resolution:
- Identify and mitigate risks associated with CQV activities, providing solutions to any challenges encountered during commissioning, qualification, or validation
- Manage protocol discrepancies and deviation investigations, root cause analysis, and CAPA (Corrective and Preventive Actions) processes to resolve issues promptly
- Provide timely updates to stakeholders regarding project status, challenges, and risk mitigation efforts
Documentation & Reporting:
- Assist in the management, preparation and review of all required CQV documentation per Client SOPs, including Design Qualification (DQ), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) protocols and reports, and validation plans
- Ensure accurate and complete documentation is maintained throughout the CQV process, ready for internal and external audits
- Provide regular reports to Capital Projects and stakeholders regarding CQV progress, milestones, and key issues
- Investigate and resolve protocols exceptions or discrepancies
- Establish appropriate metrics for measuring key project criteria and ensuring that project deliverables satisfy project requirements
Quality Assurance & Continuous Improvement:
- Ensure that all CQV activities are aligned with the Client's Quality Assurance processes and standards
- Implement continuous improvement practices and contribute to the enhancement of CQV methodologies and standards within the organization

Qualifications

Minimum of 7-10 years of experience in pharmaceutical project management with a focus on CQV, including at least 3-5 years in a leadership role
Experience in managing the lifecycle of CQV activities in a pharmaceutical construction project from design through GMP release
Strong knowledge of pharmaceutical regulations, including FDA 21 CFR Part 11, cGMP, and EMA guidelines
Proven experience in risk management, troubleshooting, and resolving CQV- related issues

Skills

In-depth knowledge of the CQV process for pharmaceutical facilities, systems, and equipment
Strong project management skills, including experience with project scheduling, budgeting, and resource allocation
Excellent leadership and team management skills, with the ability to motivate, guide, and develop a cross-functional team

Position Demands

Seeing, color perception, hearing, listening, clear speech, dexterity in hands, driving, ability to travel distances.
Full time role - flexibility to work hybrid if needed but expected on site for critical project milestones at minimum
Travel - minimum 25% unless located nearby
- Expectation is to be onsite during project execution 100%
- May attend FATs
Standard office environment: frequent use of personal computer, facsimile and copy machines, along with miscellaneous office equipment

*Job Descriptions are not exhaustive lists of all skills, responsibilities, or efforts associated with a job. They reflect principal job elements essential for performing the job and evaluating performance.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Wunderlich-Malec

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