Commissioning and Qualification (C&Q) Manager

SSOE, Inc. • Atlanta, GA

2d • $150,000 - $200,000 • Hybrid

About The Position

SSOE is seeking a Commissioning and Qualification (C&Q) Manager to lead a team of engineers and specialists delivering commissioning, qualification, and validation services to clients in pharmaceutical, medical device, and other advanced industries. The role requires strong technical expertise in C&Q practices, a deep understanding of cGMP regulations, and excellent interpersonal and organizational skills. The manager will interface with project managers, discipline leads, suppliers, contractors, and client quality assurance representatives, and will work closely with the current department manager to support a smooth transition of leadership responsibilities.

The position also contributes to business development and expands the group’s client base across pharma/biotech, medical device, food and beverage, and consumer products sectors. Responsibilities include department leadership and resource planning; oversight of commissioning and qualification activities and documentation; technical guidance; client relationship management; quality and regulatory compliance; continuous improvement; budget management; and identifying and pursuing business opportunities.

SSOE provides employees with access to industry-leading AI large language models, vibe-coding platforms, and other securely integrated advanced tools, with training and support to use AI to improve productivity, creativity, and workflows. The company describes its culture as innovation-forward and mentorship-driven, with multidisciplinary collaboration, tailored coaching, peer knowledge sharing, and structured career paths.

Requirements

• Demonstrated experience managing commissioning and qualification activities, including leadership responsibilities managing teams.
• Strong understanding of building systems, utilities such as HVAC, WFI, clean steam, and compressed air, and process equipment.
• Comprehensive knowledge of cGMP regulations, FDA/EMA expectations, GAMP principles, and industry best practices.
• Ability to manage multiple projects and deadlines in a dynamic consulting environment.
• Proficiency reviewing, interpreting, and validating complex engineering documentation, including IQ/OQ/PQ protocols, FAT/SAT reports, and design specifications.
• Advanced communication and presentation skills, with success interfacing with clients, contractors, project teams, and regulatory bodies.
• Leadership experience 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.
• Skill with the Microsoft 365 suite, including document management and collaboration tools.
• Bachelor’s degree in Engineering, Architecture, or a related technical field.

Nice To Haves

• Active Professional Engineer (PE) license or equivalent certification, preferred where responsible charge applies.
• Sector-specific experience in pharmaceutical or biopharmaceutical, aseptic processing, or medical device manufacturing environments.
• Experience with cGMP content management platforms such as Veeva Vault or Teamcenter.
• Proficiency with electronic validation software such as KNEAT or ValGenesis.
• Experience leading start-up and qualification for full production facilities, pilot plant facilities, and utility systems.
• Strong construction knowledge and ability to identify and mitigate potential C&Q risks during design and procurement phases.
• Experience with commissioning-specific software.

Responsibilities

• Lead, mentor, and manage a team of C&Q engineers and specialists.
• Oversee workload distribution and resource planning across multiple concurrent projects.
• Support staff development through training, performance feedback, technical guidance, and performance metrics.
• Provide ongoing training aligned with regulatory updates and best-practice standards.
• Prepare departmental budgets and monitor financial performance, including cost forecasting and variance analysis.
• Manage risks related to C&Q scope and integrate safety observations into corrective actions to foster a zero-incident work culture.
• Maintain team morale and foster a collaborative work environment.
• Oversee planning, execution, and documentation of commissioning and qualification activities for equipment, utilities, and building systems.
• Provide guidance on C&Q methodologies, including IQ/OQ/PQ, FAT/SAT, and risk-based approaches.
• Ensure project deliverables meet client expectations, industry standards, and regulatory requirements.
• Serve as a technical escalation point for project teams.
• Build and maintain client relationships, support client satisfaction and repeat business, and serve as a primary contact for key accounts.
• Understand client needs and propose appropriate solutions or service offerings.
• Ensure compliance with applicable cGMP, GAMP, ASTM E2500, and other industry standards.
• Review and approve qualification protocols, reports, and related documentation.
• Support continuous improvement by analyzing workflows and implementing updates to improve efficiency, reduce rework, and optimize resource allocation.
• Collaborate with leadership to identify and pursue new business opportunities.
• Engage with clients during proposal development, project scoping, and execution.
• Contribute to expanding services into adjacent industries, including food and beverage and consumer products.
• Represent the C&Q team at networking events, conferences, and industry forums.

Benefits

• Comprehensive health insurance
• Dental insurance
• Vision insurance
• Life insurance
• 401(k) retirement savings plan with company matching
• Professional development and training, including support for relevant licensure and certifications
• Generous paid time off
• Paid holidays
• Leadership incentive components and bonus opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Manager