Manufacturing Operations /Validation Manager

The Manufacturing Operations & Validation Manager is responsible for overseeing both manufacturing operations and validation processes to ensure all systems, equipment, and processes comply with regulatory standards and operate efficiently. This role combines operations management with a strong focus on validation, requiring expertise in GMP, FDA, ISO standards, and quality management systems (QMS). The position involves leading manufacturing teams, ensuring compliance, managing process validations, and driving continuous improvement in production and validation methodologies.

Key Responsibilities:

Manufacturing & Compliance Oversight

• Ensure that all finished products are manufactured, packaged, and labeled in compliance with legal and regulatory requirements.
• Ensure raw materials, components, in-process materials, and finished products meet quality and regulatory specifications.
• Collaborate with QA teams to ensure manufacturing processes align with the company’s Quality Management System (QMS).

Validation & Qualification

• Oversee the validation of manufacturing equipment, systems, and processes to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP guidelines.
• Lead qualification of new equipment, ensuring adherence to Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Ensure software and IT system validation for Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems.
• Develop and implement validation plans, protocols, and reports, ensuring they meet regulatory standards and company policies.

Process & Continuous Improvement

• Identify and implement process validation (PV) strategies to enhance efficiency, quality, and compliance in manufacturing.
• Oversee re-validation activities when process or equipment changes occur to maintain compliance.
• Lead Corrective and Preventive Actions (CAPA) by addressing deviations, conducting root cause analyses, and ensuring timely resolution of issues.
• Manage validation documentation, including protocols, reports, and Standard Operating Procedures (SOPs), in accordance with regulatory requirements.

Leadership & Team Management

• Lead and manage onshore and offshore teams, ensuring they are well-trained, motivated, and aligned with company goals.
• Provide mentorship and guidance to manufacturing and validation teams, fostering a culture of compliance and operational excellence.
• Work with training departments to ensure that teams receive proper training on procedures, regulatory compliance, and equipment handling.

Qualifications:

Education & Experience:

• Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
• 5–10 years of experience in quality, manufacturing operations, and validation in a regulated industry (pharmaceuticals, medical devices, or food manufacturing).
• 3–8 years of leadership experience, with the ability to manage onshore and offshore teams.

Skills & Knowledge:

• Strong understanding of regulatory requirements including FDA 21 CFR Part 820, GMP, and ISO 13485.
• Experience in process validation (PV), equipment qualification (IQ, OQ, PQ), and software validation.
• Ability to lead cross-functional teams, interact with senior management, and liaise with regulators or auditors.
• Strong analytical, problem-solving, and continuous improvement mindset.
• Excellent communication and leadership skills to manage teams and drive compliance.

Skills Summary:

• Core Expertise: Manufacturing operations, validation (IQ, OQ, PQ, PV), regulatory compliance (FDA, GMP, ISO).
• Industry Knowledge: Pharmaceuticals, medical devices, food manufacturing.
• Soft Skills: Leadership, problem-solving, cross-functional collaboration, regulatory communication.
• Tools: MES, ERP, quality management systems (QMS), validation documentation tools.

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.

Salary : $31 - $49