Manufacturing Project Specialist I-Sr

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY

The Manufacturing Project Specialist I-Sr will be responsible for identifying and executing projects that directly relate to process readiness, right first-time execution on the manufacturing floor and facility. This role works in close collaboration with site cross functional groups including but not limited to QA, MSAT, Validation, and Facilities/Engineering.

PRINCIPAL JOB DUTIES & RESPONSIBILITIES 

• Support the implementation of corrective actions, change controls, and general process improvements in close collaboration with Program Managers, Process Transfer, Engineering, QA, and Validation teams.
• Provide support to manufacturing staff for new equipment and processes. 
• Ensure process optimization and continuous improvement.
• Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.
• Collaborate with engineering and validation teams to implement and qualify new equipment and controls.
• Author, update, review and approve quality documents, such as Standard Operating Procedures (SOPs) and other technical procedures.
• Follow-up on production campaigns including client communication, review and approval of executed batch records, troubleshooting, handling of Change Records and CAPAs.
• Participate in customer meetings providing manufacturing updates.
• Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, working closely with other team members in a cooperative fashion to ensure project progression.
• Work closely with manufacturing operations and QA team to drive CAPAs to timely closure.
• Serve as liaison between multiple groups including Manufacturing, Quality, and Process Transfer.

KNOWLEDGE, SKILLS, & ABILITIES

• Ability to interact constructively and influence peers and support groups.
• Prior experience with technical writing and in a manufacturing environment preferred.
• Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time delivery.  Must work well on a team and be able to troubleshoot and problem solve in a cross functional team setting.  Must be proactive, action oriented, and adaptable to change.  Must be able to identify and flag risks in a timely manner to keep deliverables on track.
• Strong written and verbal communication skills are required.  Ability to read and comprehend complex subjects. Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.
• Ability to understand and apply GMP regulations as they relate to manufacturing.

TECHNICAL SKILLS

MFG Project Specialist I:

• An understanding of biopharmaceutical manufacturing process (microbial or cell culture), related equipment and purpose and function of supporting processes.
• An understanding in the application of cGMP requirements.
• Manage and own CAPAs, SOPs, and WOI revisions.
• Be point of contact for technical writing team (questions, clarifications, etc).
• Work closely with Manufacturing operations and QA team to drive CAPAs to timely closure.
• Represent the interests of the Manufacturing team in collaborative and interdepartmental projects, including but not limited to equipment onboarding, process development and onboarding tasks, manufacturing support and training.
• Follow up on production campaigns, including review and approval of documents, troubleshooting, CRs and CAPAs.
• Participate in client meetings providing manufacturing updates.

MFG Training Specialist II

• All Manufacturing Project Specialist 1 tasks.
• Own and manage change records.
• Maintain primary point of contact status for client facing manufacturing for assigned upstream or downstream function.
• Act as upstream/downstream core team representative with some managerial support.
• Support deviation investigations as needed.

MFG Training Specialist III

• All