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Manufacturing Operations Associate II

2 months ago

Atlanta, Georgia, United States Mallinckrodt Pharmaceuticals Full time

Position Overview

Key Responsibilities

Manufacturing Operations:

Perform all dispensing, sanitation, and production activities related to the preparation and manufacturing of Mallinckrodt products within a cGMP framework, ensuring meticulous attention to detail and superior documentation practices. Uphold a safe and compliant work environment adhering to cGxP standards at all times. Execute all tasks in accordance with Standard Operating Procedures (SOPs) and production batch records (PBRs). Proactively identify and communicate risks related to compliance, safety, and schedule adherence. Engage in project teams and initiatives aimed at process improvement. Assume responsibility for specific actions within Operations, such as documentation management, area inspections, out-of-specification investigations, and logbook reviews. Provide support for Engineering, Calibration, Maintenance, and Qualification tasks. Actively participate in Environmental Health and Safety (EHS) inspections and other enhancement processes. Contribute to the development and upkeep of area SOPs and batch records. Assist in training colleagues on SOPs, process execution, and equipment operation. Offer support to the Quality department as needed. Foster a culture of Engagement and Continuous Improvement by identifying and implementing opportunities for enhancing process efficiency and compliance. Support the initiation and completion of deviations, Corrective and Preventive Actions (CAPAs), and change controls for process systems. Resolve issues within the area of responsibility to ensure the seamless operation of the manufacturing area. Rigorously adhere to processes designed to protect intellectual property. Serve as a designated point of contact for the Manufacturing Operations Lead when necessary. Participate as a member of the Emergency Response Team as appropriate.

Additional Responsibilities:

Engage in ad hoc projects, goals, and objectives as they arise. This role is not shift-based but requires flexibility to support the manufacturing process.

Qualifications and Experience

A minimum of a certificate-level qualification in a relevant field (Chemistry, Engineering, Biotechnology, etc.) and/or 2-5 years of pertinent experience in a cGMP commercial manufacturing setting. Proficient understanding of production operations with a strong emphasis on attention to detail and adherence to regulatory standards. Familiarity with GMP utility systems (e.g., Water for Injection (WFI), clean steam, pharmaceutical gas systems). Experience in a Grade C/D environment. Background in dispensing operations. Experience in initiating and investigating non-conformances. Ability to thrive in a team-oriented environment. Exceptional organizational and coordination abilities. Familiarity with SAP ERP systems is advantageous. Experience applying lean principles and structured problem-solving methodologies. Proven capability to identify and drive improvement initiatives. Ability to work independently and collaboratively within a team. The ideal candidate will be able to manage their own workload routinely with minimal supervision. Experience collaborating in cross-functional teams. This job description outlines the general nature and level of work expected from the candidate. It is not intended to be an exhaustive list of all activities, duties, or responsibilities required of the incumbent. The candidate may be asked to perform additional duties as necessary, particularly in support of critical manufacturing activities.

Preferred Skills and Competencies

Strong interpersonal and communication skills. Excellent documentation capabilities. Meticulous, diligent, and rigorous attention to detail. Collaborative mindset with high levels of engagement with individuals and teams. Strong commitment to delivering results and completing work. Enthusiastic, adaptable, and eager to develop professionally. Ability to navigate ambiguity and change effectively. High levels of integrity and trustworthiness. Capability to operate efficiently with minimal supervision. Demonstrated ability to lead change initiatives. Familiarity with Six Sigma and lean tools. Ability to cultivate a culture of positive engagement.