- Oversees the Manufacturing Support Services function.
- Direct Support Services Coordinators on day-to-day activities.
- Works with manufacturing supervisors, subject matter expert(s), and quality teams to resolve deviations and track closure of any associated corrective actions;
- May author, review, and approve batch records, SOPs and Work Instructions for both original and periodic updates;
- Implements quality improvements to existing procedures and efforts to create new ones;
- Owns guidebook process to proceduralize workflows within manufacturing and cross-functional flows;
- Works with manufacturing to prepare and drive the approval of material and chemical specification documents.
Equipment and Readiness Coordination
- Opens and completes change order records for equipment movement between clean rooms;
- Creates and manages the readiness tier board for GMP manufacturing;
- Works with manufacturing to coordinate or execute water runs and media hold studies and routine equipment cleaning;
- Works with manufacturing supervision and validation to coordinate qualifications / requalification associated with equipment moves and acquisition of new equipment;
- Assists in preparing User Requirement Specifications as needed for new equipment;
- Harmonizes 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
- Participates in team projects relating to Operational Excellence;
- Works with manufacturing line management to see what AAR lessons and room walk-through observations can be converted into guidebooks to establish and document best practices to other functions within manufacturing;
- Participate in team projects relating to Operational Excellence such as Problem Analysis and Prevention.
Right-First-Time (RFT) Execution
- Works with manufacturing and quality personnel to optimize work and documentation processes and to convert such processes into guidebooks as needed to ensure systemized and efficient RFT operations;
- Leads Pre-Run Readiness activities with manufacturing as needed.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Good oral and written communication skills, interpersonal and organizational skills.
- Strong, 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 guide colleagues 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 plus three (3) years’ experience of which two (2) years must be GMP experience; OR
- Associates Degree plus five (5) years’ experience of which two (2) years must be GMP experience; OR
- High School Diploma/GED plus six (6) years’ experience of which two (2) years must be GMP experience.
- Experience with both Upstream and Downstream processes
- Six Sigma or Lean Sigma Certification