Manager, Technical Manufacturing Job Description

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Manager, Technical Manufacturing

Biomerieux , Inc - Durham, NC

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Description

Position Summary:

The Manager, Technical Manufacturing position is responsible for Front-line leadership of their teams.

All Technical / Autonomous Maintenance aspects of reagent formulation, production/packaging inspecting, preventive maintenance, cleaning, troubleshooting and/or repair of manufacturing/process equipment of their respective areas
- May provide indirect leadership for other teams as assigned.
Provide technical line support
- Execute Assigned Projects or Scope of Work
- Monitor Equipment Performance
- Collaborate with Engineering Validation Leadership
- Lead and Participate in Engineering and Interdepartmental Team Meetings
- Lead quality initiatives to improve manufacturing processes, increase product quality, improve departmental productivity/efficiency.
- User Friendly Interfacing and Computing Innovations
Following regulatory and customer requirements.
Development of internal candidates by providing expanded responsibilities in relation to team leadership, including personnel performance management and accountability for team performance metrics and projects.

Primary Responsibilities:

Management

- Coordinate department requests for equipment or personnel support that impact Manufacturing operations.
  - This may include but is not limited to Engineering, QC, R&D, Validation or Maintenance.
- Oversee and assist Technicians in management of daily activities including scheduling cleaning activities.
- Maintain an efficient and effective workforce.
- Contribute to team goal development, status tracking and communication through the PMP (Performance Management Program) process Communicate with other departments (i.e. Materials Management, Production Operations, and Quality Control as needed to ensure the timely and efficient production of all of our customer requirements.
- Conduct meetings (team and/or safety) as needed, keep records/documentation of information discussed.
- Perform other duties as assigned by Management.

Leadership / Employee Development

- Provide performance feedback coaching and development for Team Leads, Tech Leads, Setup Techs and/or team members.
- Complete formal performance evaluations for all direct reports.
- Inspire and motivate production teams to achieve top performance.
  - Promote self-growth and internal development within the team.
- Demonstrate and work towards developing the following attributes:
  - Inspire, motivate, and guide others toward goal accomplishments. Consistently develop and sustain cooperative working relationships. Encourage and facilitate cooperation within the organization and with customer groups; foster commitment, team spirit, pride, and trust. Develop leadership in others through coaching, mentoring and guiding.
- Convey goals and objectives clearly and in a compelling manner; listen effectively and clarify information as needed; interpret verbal and non-verbal messages that others communicate; produce clear status reports; communicates tactfully and candidly.

Technical Line Support

- Execute Assigned Projects or Scope of Work
  - Manage project schedules and project budgets as assigned.
  - Work in a team environment to complete projects
- Monitor Equipment Performance
  - Review SPC/OEE results, analyze data, and implement improvements as required.
  - Provide technical support for the area equipment and processes.
  - Review in-process scrap and act to improve as required.
- Lead and Participate in Manufacturing and Interdepartmental Team Meetings
  - Actively participate and facilitate team meetings as required.
  - Act as SME to assigned projects or scope.
  - Assist project leaders to close the projects after they have been completed.
- User Friendly Interfacing and Computing Innovations
  - Provide first line support for programming support.
  - Interdepartmental coordination including Operational Technology and Automation for the successful development and / or implementation of software programs.
- Lead quality initiatives to improve manufacturing processes, increase product quality, improve departmental productivity/efficiency.

Documentation & Training Compliance

- Utilize a variety of software systems to support daily work activities (i.e. Proficient/SPC, Rockwell, TrackWise, LiveLink/DocLink, SAP, BRAM, Compliance Wire, etc.).
- Ensure overall team training compliance is maintained current for processes and procedures relevant to all activities and coordinate cross-training among roles to create staffing flexibility and increased depth.
- Ensure that Manufacturing batch records and other documentation are prepared, completed and stored at the highest standards according to company policies and procedures to support manufacturing, maintenance of device history records, logs/logbooks and training requirements consistent with cGMP, ISO, and all applicable regulatory policies/regulations.
- Provide assistance with the creation, review and revision of instructions and SOPs necessary for the Manufacture of BacT/ALERT products.

Continuous Improvement

- Lead and promote continuous improvement through team and individual initiatives.
- Identify areas of deficiency and implement practices to improve employee safety and to reduce the cost incurred through excessive scrap, poor workflow/process design and others.
- Lead project teams and/or serve as a project team member to reduce scrap, improve product quality, decrease operational costs, and increase departmental efficiency/productivity.
- Serve as change agent by driving the required cultural transformation and the adoption of successful process improvement practices.

Quality / Manufacturing Compliance

- Coordinate with the shift Manufacturing Compliance team member(s) to mitigate errors via the Right The First Time (RTF) initiatives.
- Ensure Quality Assurance is communicated to the team for minimal deviations and error free performance.
- Maintaining the BacT/ALERT manufacturing operation so that it is GMP compliant and meets all regulatory requirements.
- Review documentation to support manufacturing, maintenance history records and training requirements that adhere to all applicable procedures and regulations.
- Ensure the most recent information related to manufacturing and maintenance is communicated and/or documented for compliance, history, and reliability.
- Assist with and/or lead Manufacturing investigations, CAPA actions, In-Process Events (IPEs) and other process equipment related quality concerns.
- Ensure that Manufacturing batch records and other documentation are prepared, completed and stored at the highest standards according to company policies and procedures to support manufacturing, maintenance of device history records, logs/logbooks and training requirements consistent with cGMP, ISO, and all other applicable policies and regulations.
- Provide support in FDA, ISO, customer and other inspections and audits

Education, Skills, & Experience:

HS Diploma with 6 years regulated production/ operations environment experience & 5 Years Supervisory Experience OR
- Associates Degree or relevant Technical Certifications with 6 years regulated production/operations environment experience Experience + 4 Years Supervisory Experience OR
- Bachelor's Degree with 5 years regulated production/ operations environment experience & 3 Years Supervisory Experience

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics' application process by contacting us via telephone at ([redacted], by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).