Job Summary/ Objective

The Commissioning & Qualification (C&Q) Specialist supports the qualification lifecycle of manufacturing and packaging equipment within a GMP – regulated environment. This role ensures systems, utilities, and equipment meet established quality and regulatory requirements through the execution of protocols, troubleshooting activities, and effective change control management.

Key Responsibilities

• Perform end-to-end qualification lifecycle activities, including commissioning, IQ, OQ, and PQ for manufacturing and packaging equipment.
• Prepare, review, and execute qualification protocols and final reports in accordance with GMP and internal quality standards.
• Generate and manage change controls associated with equipment, processes, and qualification activities.
• Conduct troubleshooting to identify and resolve equipment or process deviations during qualification or commissioning phases.
• Ensure all work complies with GMP, regulatory requirements, and company procedures.
• Collaborate with cross-functional teams such as Engineering, Quality, Operations, and Technical Services to support project deliverables.

Profile and Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• 2–5 years of experience in Commissioning, Qualification, Validation, or Engineering roles within GMP-regulated environments.
• Hands-on experience with manufacturing and packaging equipment qualification.
• Strong understanding of the qualification lifecycle (Commissioning, IQ/OQ/PQ).
• Ability to troubleshoot equipment performance or documentation issues.

Skills

• Strong knowledge of GMP, FDA, and regulatory compliance requirements.
• Proficiency developing and executing IQ/OQ/PQ protocols.
• Technical understanding of manufacturing and packaging equipment operation.
• Analytical and problem-solving abilities for equipment and process troubleshooting.
• Excellent written and verbal communication skills, with the ability to articulate complex technical concepts clearly and compellingly.
• Effective communication and teamwork skills for cross-functional collaboration.
• Time management and ability to prioritize multiple activities in fast-paced environments.
• Knowledge of change control systems and deviation management processes.
• Fluent in both English and Spanish.

Synerlution is committed to providing equal employment opportunities for all employees and applicants, regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, or veteran status. We feel that having a diverse staff increases our capacity to drive synergy through solutions for our clients. We are committed to fostering an inclusive environment in which all employees feel comfortable sharing their unique ideas and talents.