Senior Manufacturing Tech (Open)
Senior Manufacturing Tech
Job Description
This is a more experienced position requiring sound knowledge of manufacturing systems, methods and procedures, and regulatory affairs.
Job Responsibilities
- Works on more complex, non-routine projects/assignments where analysis of procedures or operations requires a review of identifiable factors.
- Exercises judgment within well-defined and established procedures and practices to determine appropriate action - identifies problems and generates alternatives and recommendations within defined processes.
- Coordinates planning, organization, and implementation of projects within specified objectives.
- Writing skills are refined and participates in writing of communications, procedures and protocols.
- Acts as a point of escalation for junior staff.
- Demonstrates basic knowledge of Lean Manufacturing/Six Sigma skills.
- Demonstrates capability in covering for Team Lead Activities during absence (except Human Resource Management).
- May fill in for basic shift supervisory roles.
- Highly proactive in the identification and implementation of improvement activities
- Assists in manufacturing product
- Has daily interaction with department members to ensure production proceeds as scheduled
- Responsible for the processing of product hydrations.
- Monitors and controls weights, volumes, temperatures, pressure, and pH.
- Participates in production processes, including cleaning and set-up.
- Updates SOPs and Master Production Batch Records.
- Interacts with QA/QC and Inventory Control to ensure that all raw materials and components are available for production usage.
- Interacts with outside vendors on productions supplies and materials. Consistently adheres to cGMPs.
- May aid in the training of newer employees in standard operating procedures and processes.
- Has daily interaction with department members to ensure production proceeds as scheduled.
- Works to demanding production schedules and strict compliance/quality requirements.
- Supports continuous improvement and process reliability through involvement in process improvement teams.
Knowledge and Skills
- Demonstrates good verbal, written, and interpersonal communication skills.
- Working knowledge of Good Manufacturing Practices (GMPs)
- Works on non-routine to somewhat complex problems, requiring evaluation of multiple factors before taking action.
Typical Education and Experience
- HS diploma, and minimum 6 years of relevant experience.
Prior experience in a cGMP related industry is required, within Biopharmaceutical or Pharmaceutical industry preferred