Commissioning and Qualification (C&Q) Manager

About the role

SSOE is seeking a Commissioning and Qualification (C&Q) Manager to lead a team of engineers and specialists responsible for delivering commissioning, qualification, and validation services to clients in the pharmaceutical, medical device, and other advanced industries. Key responsibilities include:

Responsibilities

• Lead, mentor, and manage a team of C&Q engineers and specialists.
• Oversee workload distribution and resource planning to support multiple concurrent projects.
• Support staff development through training, performance feedback, and technical guidance, establishing performance metrics and providing ongoing training aligned with regulatory updates and best practice standards.
• Maintain strong team morale and foster a collaborative work environment.
• Oversee the planning, execution, and documentation of commissioning and qualification activities for equipment, utilities, and building systems.
• Provide expert guidance on commissioning and qualification methodologies, including IQ/OQ/PQ, FAT/SAT, and risk-based approaches.
• Ensure that all project deliverables meet client expectations, industry standards, and regulatory requirements.
• Serve as a technical escalation point for project teams.
• Build and maintain strong client relationships, ensuring high satisfaction and repeat business.
• Represent the C&Q team in networking events, conferences, and industry forums.

Requirements

• Demonstrated experience in commissioning and qualification management, including leadership responsibilities managing teams.
• Strong understanding of building systems, utilities (HVAC, WFI, clean steam, compressed air, etc.), and process equipment.
• Comprehensive knowledge of cGMP regulations, FDA/EMA expectations, GAMP principles, and industry best practices.
• Demonstrated ability to manage multiple projects and deadlines in a dynamic consulting environment.
• Proficient in reviewing, interpreting, and validating complex engineering documentation including IQ/OQ/PQ protocols, FAT/SAT reports, and design specifications.
• Advanced communication and presentation skills with demonstrated success interfacing with clients, contractors, project teams, and regulatory bodies.
• Demonstrated success in leadership roles emphasizing mentorship, staff development, and cross-functional collaboration in complex project delivery.
• Experience developing and managing departmental budgets and leading strategic planning initiatives related to commissioning services.
• Familiarity with project cost control, schedule integration, and resource allocation in a matrixed project management environment.
• Skilled in Microsoft 365 suite including document management and collaboration tools; experience with commissioning-specific software is an advantage.

Qualifications

• Bachelor’s degree in Engineering, Architecture, or a related technical field; active Professional Engineer (PE) license or equivalent certification preferred where responsible charge applies.
• Salary Range: $150,000 - $200,000/year depending on location, education, depth of relevant experience, and any specialized licensure/certifications. Opportunity for ample rewards, leadership incentive components, and generous bonus opportunities.
• Benefits: Includes comprehensive health, dental, and vision insurance, life insurance, 401K retirement savings plan (with company matching), opportunities for professional development and training (including support for relevant licensure & certifications), and generous PTO & paid holidays.

Skills

• Experience with cGMP content management platforms such as Veeva Vault, Teamcenter.
• Proficiency with electronic validation software such as KNEAT, ValGenesis.
• Experience leading start-up and qualification for full production facilities, pilot plant facilities, and utility systems.
• Strong construction knowledge with the ability to identify and mitigate potential C&Q risks during design and procurement phases.

Benefits

• Comprehensive health, dental, and vision insurance.
• Life insurance.
• 401K retirement savings plan with company matching.
• Opportunities for professional development and training (including support for relevant licensure & certifications).
• Generous PTO & paid holidays.

Pay

$150,000 - $200,000/year depending on location, education, depth of relevant experience, and any specialized licensure/certifications.

Schedule

Full Time