OverviewSSOE is looking to hire a Commissioning and Qualification (C&Q) Manager. You will 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. This role requires strong technical expertise in C&Q practices, deep understanding of cGMP regulations, and excellent interpersonal and organizational skills. You will be interfacing with project managers, discipline leads, suppliers, contractors, and client quality assurance representatives to provide guidance to your team and to the client. The selected candidate will work closely with the current department manager to ensure a smooth transition of leadership responsibilities.
This individual will also be responsible for contributing to business development initiatives and expanding the group’s client base across pharma/biotech, medical device, food & beverage, and consumer products sectors.
Responsibilities
Department Leadership & Management
- 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.
- Oversee departmental budget preparation and monitor financial performance, including cost forecasting and variance analysis, ensuring C&Q projects remain within scope and budget.
- Manage risk identification and mitigation strategies related to C&Q scope and integrate safety observations into corrective actions, fostering a zero-incident work culture.
- Maintain strong team morale and foster a collaborative work environment.
Technical & Project Responsibilities
- 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.
- Serve as a primary point of contact for key client accounts.
- Understand client needs and propose appropriate solutions or service offerings.
Quality & Compliance
- Ensure compliance with applicable cGMP, GAMP, ASTM E2500, and other industry standards for pharma/biotech and medical device manufacturing.
- Review and approve qualification protocols, reports, and related documentation.
- Support continuous improvement initiatives to streamline C&Q processes and enhance service quality by analyzing workflows, implementing updates to enhance efficiency, reduce rework, and optimize resource allocation.
Business Development & Growth
- Collaborate with leadership to identify and pursue new business opportunities.
- Engage with clients during proposal development, project scoping, and execution phases, demonstrating technical leadership and business development acumen to expand SSOE’s footprint within our market sectors.
- Contribute to strategic expansion of services into adjacent industries (e.g., food & beverage, consumer products).
- Represent the C&Q team in networking events, conferences, and industry forums.
Qualifications
- 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.
- 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.
Preferred Qualifications
- Sector-specific experience within pharmaceutical biopharmaceutical, aseptic processing, or medical device manufacturing environments.
- 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.
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