Summary: The Manufacturing Coordinator assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor by developing and driving systems for readiness, compliance, and permanence of new knowledge. The Manufacturing Coordinator will assist in supporting the timely release and disposition of batches and other post-execution activities.
- Responsible for participating in the following activities within the Manufacturing Support Services function:
- Assists the Supervisor, Manufacturing Support Services, the Manufacturing Supervisors, subject matter expert(s), and quality teams to resolve deviations and track closures of any associated corrective actions.
- May assist the Supervisor with authoring, reviewing, and approving batch records, SOPs and Work Instructions for both original and periodic updates.
- Assists manufacturing in preparing and driving the approval of material and chemical specification documents.
Equipment and Readiness Coordination
- Supports Supervisor in opening and completing change order records for equipment movement between clean rooms.
- Works with manufacturing to coordinate or execute water runs and media hold studies and routine equipment cleaning.
- Works with validation to coordinate qualifications and re-qualifications associated with equipment moves and acquisition of new equipment.
- Assist in preparing User Requirement Specifications as needed for new equipment.
- Work with Supervisor in harmonizing best readiness practices between sites.
- Works with manufacturing and supply chain to follow-up on material ordering and receipt for GMP manufacturing.
- Originates and tracks manufacturing work orders as necessary.
Continuous learning and improvement
- Participate in team projects relating to Operational Excellence.
- Assists Supervisor and manufacturing line management to see what AAR lessons and room walk-through observations can be converted into guidebooks to establish and spread best practices to other functions within MFG.
- Participates in team projects relating to Operational Excellence such as Problem Analysis and Prevention.
- Assists team in creating guidebooks to proceduralize workflows within manufacturing and cross-functional flows and trains MFG personnel on their use.
Right-First-Time (RFT) Execution
- Coordinates or may lead Pre-Run Readiness activities within manufacturing.
- Works with technical support personnel to gather post-execution data.
- Performs all other duties as assigned.
Required Skills & Abilities:
- Good oral and written communication skills, interpersonal and organizational skills.
- Practical understanding of equipment used in bioprocessing (downstream and/or upstream)
- Proficient with Microsoft Office applications.
- Good self-discipline and attention to detail.
- Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
- Experience working in cleanroom environments.
- Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the manufacturing facilities.
Working Conditions & Physical Requirements:
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
- Attendance is mandatory.
- Bachelor’s Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and two (2) years of biopharmaceutical manufacturing (GLP or GMP) or supply chain experience; OR
- Associate’s Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and five (5) years of biopharmaceutical manufacturing (GLP or GMP) or supply chain experience; OR
- High School Diploma and sever (7) years of biopharmaceutical manufacturing (GLP or GMP) or supply chain experience.
Experience with both Upstream and Downstream processes