Manager, Visual Inspection Job at Resilience in Blue Ash
Resilience, Blue Ash, OH, United States
A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position Summary
This position is a leader for the Process Operation (Visual Inspection). In this capacity, the Visual Inspection Manager manages the Process Operation to produce high quality product in accordance with the operating strategy. As a responsible leader for the operation (potentially with other Supervisors), this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as EHS obligations and Resilience standards. This manager position will eventually hire and have 4 supervisors within their reporting structure.
Position Responsibilities
Responsible to build visual inspection processes and procedures for the new cartridge inspection line
Responsible to build the eventual visual inspection manufacturing team of supervisors and technicians
Responsible for the operational side of the tech transfer of the new cartridge inspection line
Provides direction to personnel in the efficient use of equipment and materials to produce quality products in accordance with the Operations Plan or Rhythm Wheel
Responsible for all Operations activity to include coordination of support staff, scheduling and improvement
Promotes the use of safe work practices during all aspects of production and ensures all external and Resilience EHS standards are met on a daily basis
Accountable for training of personnel on equipment, processes and Standard Operating Procedures
Ensures that cGMP's are used and followed during production of products so that all FDA and international regulations are met. Responds to monthly internal audit observations
Promotes a positive work environment and communicating information to employees and responding to their concerns
Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.
Generates reports for deviations, assists in the investigations, and recommends/implements solutions to resolve deviations. Approves deviation investigations as appropriate. Responds to product defect notifications.
Authors, reviews, and approves Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies
Promotes and encourages continuous improvement in efficiency, quality, production, and safety through the use of team driven processes and key performance indicators and recognition and rewarding high performance
Collaborates with Technical Teams to optimize process performance
Participates in the design, selection, installation, and qualification of new equipment, facilities, and processes
Reviews, approves, and implements change control
Provides career development and performance management for direct reports
Co-owns life cycle management of PET/facility assets
Works collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors
Maintains presence across multiple operating shifts
Minimum Qualifications
Experience in GMP or regulated production environment
Previous supervisory experience
Experience working in a LEAN manufacturing environment
Knowledge of FDA cGMP
Strong communication and leadership skills
Problem solving skills
Preferred Qualifications
Bachelor of Science in engineering, pharmacy, related science, or business
Previous managerial experience
Working knowledge of LDMS, Microsoft applications, SAP, Veeva
Training or experience in visual inspection, packaging, validation, technology transfer, change control
Knowledge or previous experience in managing technical programs/projects
Strong mechanical, electrical, troubleshooting, and problem-solving abilities
Ability to direct and participate in cross-functional teams
Project Management skills
Work Schedule
During the project portion of this role within MSAT, the work schedule will be dayshift Monday-Friday. When this role transitions into the operations team at commercial handover, this role is expected to flex their schedule to work across shifts at times. The work schedule listed reflects the employee's expected schedule at the time of hire.
The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Sponsorship
Sponsorship or support for work authorization, including visas, is not available for this position.
Equal Employment Opportunity
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Benefits
Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.
Our target base pay hiring range for this position is $100,000.00 - $148,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge.
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Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position Summary
This position is a leader for the Process Operation (Visual Inspection). In this capacity, the Visual Inspection Manager manages the Process Operation to produce high quality product in accordance with the operating strategy. As a responsible leader for the operation (potentially with other Supervisors), this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as EHS obligations and Resilience standards. This manager position will eventually hire and have 4 supervisors within their reporting structure.
Position Responsibilities
Responsible to build visual inspection processes and procedures for the new cartridge inspection line
Responsible to build the eventual visual inspection manufacturing team of supervisors and technicians
Responsible for the operational side of the tech transfer of the new cartridge inspection line
Provides direction to personnel in the efficient use of equipment and materials to produce quality products in accordance with the Operations Plan or Rhythm Wheel
Responsible for all Operations activity to include coordination of support staff, scheduling and improvement
Promotes the use of safe work practices during all aspects of production and ensures all external and Resilience EHS standards are met on a daily basis
Accountable for training of personnel on equipment, processes and Standard Operating Procedures
Ensures that cGMP's are used and followed during production of products so that all FDA and international regulations are met. Responds to monthly internal audit observations
Promotes a positive work environment and communicating information to employees and responding to their concerns
Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc.
Generates reports for deviations, assists in the investigations, and recommends/implements solutions to resolve deviations. Approves deviation investigations as appropriate. Responds to product defect notifications.
Authors, reviews, and approves Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies
Promotes and encourages continuous improvement in efficiency, quality, production, and safety through the use of team driven processes and key performance indicators and recognition and rewarding high performance
Collaborates with Technical Teams to optimize process performance
Participates in the design, selection, installation, and qualification of new equipment, facilities, and processes
Reviews, approves, and implements change control
Provides career development and performance management for direct reports
Co-owns life cycle management of PET/facility assets
Works collaboratively within and across PETs to ensure flow of product, sharing of best practices, and lean behaviors
Maintains presence across multiple operating shifts
Minimum Qualifications
Experience in GMP or regulated production environment
Previous supervisory experience
Experience working in a LEAN manufacturing environment
Knowledge of FDA cGMP
Strong communication and leadership skills
Problem solving skills
Preferred Qualifications
Bachelor of Science in engineering, pharmacy, related science, or business
Previous managerial experience
Working knowledge of LDMS, Microsoft applications, SAP, Veeva
Training or experience in visual inspection, packaging, validation, technology transfer, change control
Knowledge or previous experience in managing technical programs/projects
Strong mechanical, electrical, troubleshooting, and problem-solving abilities
Ability to direct and participate in cross-functional teams
Project Management skills
Work Schedule
During the project portion of this role within MSAT, the work schedule will be dayshift Monday-Friday. When this role transitions into the operations team at commercial handover, this role is expected to flex their schedule to work across shifts at times. The work schedule listed reflects the employee's expected schedule at the time of hire.
The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Sponsorship
Sponsorship or support for work authorization, including visas, is not available for this position.
Equal Employment Opportunity
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Benefits
Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.
Our target base pay hiring range for this position is $100,000.00 - $148,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge.
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