Manufacturing Operations (Validation Manager)

The Manufacturing Operations/Validation Manager is responsible for overseeing manufacturing operations and validation processes to ensure that all systems, equipment, and processes comply with regulatory standards and function optimally. This role ensures that finished products meet legal, regulatory, and quality requirements, including adherence to specifications for raw materials, components, intermediate materials, and finished products. Based in Richmond, VA, this position is open to Canadian citizens eligible for a TN visa.

Key Responsibilities:

Manufacturing Oversight:

• Ensure all finished products are manufactured, packaged, and labeled in compliance with regulatory and legal requirements.
• Oversee production processes to guarantee adherence to specifications for raw materials, components, and finished product attributes.
• Drive operational efficiency and continuous improvement in manufacturing operations.

Validation Management:

• Oversee the validation of systems, equipment, and processes, ensuring compliance with IQ, OQ, and PQ protocols.
• Ensure all systems and processes meet applicable regulatory standards and operate as intended.

Regulatory Compliance:

• Maintain compliance with FDA, GMP, and other relevant regulatory standards.
• Ensure that manufacturing and validation documentation is complete, accurate, and audit-ready.

Quality Assurance:

• Develop and maintain quality systems to monitor and control manufacturing processes.
• Collaborate with cross-functional teams to address quality deviations, implement corrective actions, and prevent recurrence.

Leadership and Collaboration:

• Lead and mentor teams in manufacturing and validation activities.
• Work with cross-functional teams, including quality, engineering, and regulatory affairs, to ensure alignment on operational goals.

Documentation and Reporting:

• Oversee the preparation of validation protocols, test plans, and summary reports.
• Ensure proper documentation of manufacturing processes, quality metrics, and validation activities.

Qualifications:

Education:

• Bachelor’s degree in Engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.

Experience:

• 7–10 years of experience in manufacturing operations and validation within a regulated industry such as pharmaceuticals, biotechnology, or medical devices.
• Strong track record of managing both manufacturing and validation processes.

Skills and Knowledge:

• In-depth knowledge of regulatory standards (e.g., FDA, GMP) and validation protocols (IQ, OQ, PQ).
• Strong understanding of manufacturing processes, quality systems, and operational efficiency.
• Excellent leadership, organizational, and problem-solving skills.
• Experience with continuous improvement methodologies and tools.

Skills Summary:

• Core Expertise: Manufacturing operations, validation management (IQ, OQ, PQ), regulatory compliance.
• Industry Knowledge: FDA, GMP, quality assurance systems.
• Soft Skills: Leadership, problem-solving, organizational, collaboration.
• Tools: Validation documentation tools, quality management systems.

The pay range that the employer in good faith reasonably expects to pay for this position is $31.44/hour - $49.12/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis. Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.