Manufacturing Senior Specialist

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The Senior Manufacturing Specialist is responsible for assisting the manufacturing team in a variety of complex tasks in accordance with the FDA and other regulatory agencies expectations while following all safety and quality guidelines of PCI. Incumbent collaborates with the manufacturing department in the execution of production across multiple shifts against department operational goals. This position will be the SME within the operations processes and is expected to be extremely versed in validation, regulatory and quality requirements as it pertains to cGMP. As the process operations subject matter expert, the incumbent is expected to take a lead role in process improvement initiatives.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Ensure efficient operation of process floor activities by developing/improving processes, materials, GMP and safety controls
• Collaborate with the Quality, Operations, Material Management, Engineering, MTS, Validation, Facilities, Finance, and R&D teams to optimize processes, applying Lean principles
• Drive efforts to address regulatory compliance issues related to production.
• Work closely with Operations Management to provide guidance to staff in alignment with cGMP requirements, department goals and corporate quality standards
• Proactively identify, assess, and mitigate operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams
• Ensure manufacturing SOPs and batch records reflect practice, and are aligned to cGMPs/ISO and corporate standards
• Author and perform investigations, deviations, CAPAs, and other GMP documentation and ensuring timely completion
• Ensure work done by enabling/support groups is completed to standards. Participates in inspections conducted by external regulators, as required
• Identify continuous improvement opportunities to improve processes and practices and makes changes in conjunction with supervisors and operators
• Partner with cross-functional groups to evaluate and drive resolution of operational issues and proactively drive continuous improvement projects to completion
• Successfully participate in media fill / aseptic proficiency test and maintains qualification if applicable.
• Works within defined processes steps and methods, and will assist in developing procedures for new assignments or tasks
• As the SME, assist in manufacturing operations to provide training and guidance as necessary
• As the SME, you will train potential operations trainers and operators
• Acts as Liaison and SME for new projects, creates processes and appropriate SOPs
• Other duties as assigned

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Ability to lift 25 pounds
• Ability to stand, sit or remain in the same position for long periods of time
• May be required to travel between sites

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Interacts with cross functional support teams such as Quality, Operations, Materials Management, Engineering, MTS, R&D, Validation, etc.
• TRAVEL <10%

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 10+ years’ experience with GMP, ISO and/or an FDA regulated environment is required.
• 6+ years of experience in a cGMPs/ISO environment in an operations role. Strong understanding of cGMPs
• Strong technical writer and SME in