Senior Manufacturing Job Description
Senior Manufacturing Duties & Responsibilities
To write an effective senior manufacturing job description, begin by listing detailed duties, responsibilities and expectations. We have included senior manufacturing job description templates that you can modify and use.
Sample responsibilities for this position include:
Senior Manufacturing Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Manufacturing
List any licenses or certifications required by the position: ISO, CPIM, 9000, PMP, APICS, CPSM, ISM, CSSP, LEAN, NADCAP
Education for Senior Manufacturing
Typically a job would require a certain level of education.
Employers hiring for the senior manufacturing job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Manufacturing, Education, Mechanical Engineering, Technical, Science, Industrial Engineering, Industrial, Manufacturing Engineering, Electrical Engineering
Skills for Senior Manufacturing
Desired skills for senior manufacturing include:
Desired experience for senior manufacturing includes:
Senior Manufacturing Examples
Senior Manufacturing Job Description
- Responsible for completing assigned tasks which may include preparing small equipment, cleaning and sterilizing vessels, preparing solutions, monitoring and operation biochemical processing equipment while adhering to Safety, cGMP and Biochemical Manufacturing guidelines
- Plan and design manufacturing processes in a high rate of production environment
- Maximize efficiency by analyzing layout of equipment, workflow, assembly methods and work force utilization
- Determines parts and tools needed in order to achieve manufacturing goals according to product specifications
- Assist in the development of technical portions of new business proposals, including selection of manufacturing methods and production processes with estimated costs to implement
- Ensure all assigned tasks are performed as per safety requirement
- Responsible for managing and maintaining Process Documentation to include Routings, Standard Work Instructions, PFMEA’s, Visual Aids, Plant Layout, Training Documents
- Collaborate with design engineers, technicians, touch labor, production personnel, material planners, production control personnel, and production managers
- Develop proposals for new or changed work when requested by management in a timely manner
- Fulfills the role of Team Lead in the absence of the team supervisor
- Intermediate to advanced Excel skills including pivots and v-lookups (macros +)
- Cost accounting or plant accounting plus
- SAP strongly preferred or a quick learner with large ERP experience
- CPA or MBA plus
- Size of company open
- Operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas
Senior Manufacturing Job Description
- Collaborating with R&D Engineers in developing new product designs within a cross-functional team environment, specifically to develop innovative manufacturing solutions for Spinal implantable devices and reusable instruments
- Provide detailed assessments and critical Design for Manufacturing review of engineering designs/drawings of components and assemblies
- Assess the design intent, manufacturability, proper dimensioning and tolerancing of components and assemblies to allow product to transition into the manufacturing environment
- Providing back-up manufacturing engineering support as requested
- Leading or supporting manufacturing transfer projects as requested
- Supporting regulatory requests for design, testing, and manufacturing documentation and analysis
- Maintains understanding of products, manufacturing processes, and product applications
- Responsible for collection, analysis, interpretation, processing and presentation of numerical information relative to process validation in a cGMP /CBER regulated medical device manufacturing environment
- May be asked to represent the organization at meetings such as shift scheduling meeting, MDI, deviation review meetings, and project meetings
- Specific role may focus in skill areas such as electrical, mechanical, automation or process engineering
- Heating systems- I/R, convection, quartz
- Motors, gearing systems
- Workmanship standards, IPC-A-610
- College degree in an Engineering field
- Fully bilingual (English & Spanish) communication both oral and written
- Degree/Diploma in Biotechnology or related discipline
Senior Manufacturing Job Description
- Complete sales & use tax filings
- Calculate commissions and royalty payments
- The Production Manager is a key position within Operations
- Technical Product Lead (TPL) for the aducanumab process
- Set validation strategy for aducanumab in alignment with the Regulatory filing strategy, and ensures that validation strategy carries through to new biomanufacturing cells that may be brought on-line
- Lead technical projects towards improved process robustness or process outputs
- Provides statistical analyses in comprehensive written reports or sampling plans, as appropriate
- Leads or participates in process FMEA and implementation and validation of appropriate process controls
- Leads or participates in the development and implementation of statistical models and sampling plans for application in validation
- Generates and analyzes control charts as part of periodic trend analysis and develops statistical reports with data interpretation as part of the validation lifecycle (validation, monitoring, and revalidation)
- Must be able to wear appropriate clean room attire
- People management and LER management, Ensure Site is union free, Ensure PER (positive employee relationship) & LER (Labor employee Relationship) surveys are done on periodic basis and there is complete employee engagement
- Engineering skills in methods, time/motion studies, materials, and metal working techniques
- Minimum of ten (10) years supervisory experience, in the pharmaceutical or medical device industry
- BS in Biotechnology, Biology, Chemistry, or equivalent
- Experience in the lead and execution of the Process/Failure Mode and Effects Analysis process tools
Senior Manufacturing Job Description
- Makes recommendations, and when appropriate, acts independently to resolve scientific problems encountered during experimental procedures to improve productivity of results
- Serves as a statistical analysis subject matter expert for assigned projects
- Must be able to communicate statistical approach and analysis in an understandable manner to people with little or no knowledge of statistics
- Provides leadership and direction to the plant accounting team to ensure the financial accounting and reporting needs of the plant are met to enable the plant management team to meet their budgeted financial goals and objectives
- Works with the corporate finance/business unit integration personnel on a number of initiatives including
- Process requisitions from SAP to support operational demands
- Monitor material requirements and schedule adjustments to insure support for production
- Provide purchasing assistance to support design to cost activities and engineering changes
- Inventory management to align with plant initiatives
- This is a day-shift position but flexibility is needed to cover other shifts for vacation and to meet other business needs
- Proficiency in SolidWorks or other 3D modeling design software and Microsoft office suites
- Demonstrated attention to details and multi-task skills
- Develop, revise and review CNC/PLC programs as it relates to the process equipment within the operations
- Willingness to travel as required, estimated 5%
- Experience with various computer software and applications such as CAD/CAM, Excel, Word, MS Project, Mini – tab
- Validation/qualification (IQ, OQ, PQ) experience, CAD skills, able to read technical drawing
Senior Manufacturing Job Description
- Driving LEAN manufacturing implementation focused on maintaining SWIP throughout the process, executing to Lead Time and delivering at pull to all internal customers
- Lean Manufacturing & Training – create and/or maintain purposeful metrics to measure performance and lead team to drive improvement projects
- Supervise all essential activities that are necessary within the assigned work center
- Proactively monitor production schedules, forecasts, and customer order status, implementing corrective actions to meet factory service schedule
- Responsible for quality output of assigned production area
- Lead, coach, mentor team leaders to meet or exceed job requirements
- Initiate and implement process improvements and cost savings projects
- Ensure that each team personnel are up to date on all training requirements
- Ensure compliance with internal policies and procedures, cGMP, ISO, FDA, and OSHA
- Working with team leaders on employee performance and development activities
- Leadership/management experience in pharmaceutical manufacturing with experience in aseptic processing or biologic bulk drug substance delivery
- High school diploma/GED with 1-3 years in a cGXP manufacturing environment, or Bachelor’s degree with no prior experience
- Biotech Certificate or Associates degree with 1-3 years of experience in a cGXP environment, or Bachelor’s degree with 1-2 years of experience
- Five to Ten years work experience in high volume processing of automotive components and assembly for driveline products required
- Familiarity with FDA regulatory requirements, GMP, ISO, lean, process validation and six sigma methodologies
- Demonstrated ability to gather, analyze and evaluate data recommend actions