Equipment Engineer II

Regenity Biosciences; Allendale (NJ); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Company performance bonus eligibility

401(k) plan with company contribution

Paid time off and paid holidays

Medical, prescription, dental, and 
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Company-paid life and AD&D insurance

Wellness Program and EAP

Tuition Reimbursement

Job summary

Regenity Biosciences seeks an Equipment Engineer II to support manufacturing operations and validation activities, driving safety, productivity, yields, and cost efficiency. The role requires a solid understanding of manufacturing processes and equipment, with the ability to contribute to strategic and operational objectives in a regulated environment.

The ideal candidate will perform commissioning/qualification of new equipment, write SOPs, troubleshoot issues, and work with R&D to transfer

Qualifications

• Bachelor's degree in Mechanical Engineering or equivalent required.
• Experience in a regulated industry (Medical Device/Pharma/ISO 9000+) preferred.
• Strong writing and detailed document-review abilities.
• Ability to manage change and learn新 concepts quickly.
• Excellent verbal and written communication; able to work in a team.

Responsibilities

• Perform commissioning and qualification of new equipment.
• Prepare and review equipment qualification reports.
• Write or revise standard operating procedures.
• Participate in new equipment design, selection, startup and optimization.
• Troubleshoot equipment performance issues incl. root cause analysis.
• Transfer new equipment into manufacturing with R&D and others.
• Evaluate processes and propose improvements or fixes.
• Work independently or with other engineers/scientists.
• Improve overall equipment reliability across manufacturing operations.
• Troubleshoot/optimize packaging and filling equipment for throughput and cost.
• Program software and perform software validation on various equipment.
• Manage large-scale equipment projects with a team.

Skills

Problem solving

Strong communication

Self-starter

Team player

Documentation

Education

Bachelor's degree in Mechanical Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Position Summary/ Objectives

The Equipment Engineer II will be responsible for supporting the manufacturing operations and validation activities with the goal of continuously improving safety, productivity, yields, process reliability and manufacturing costs. This position ensures that the solid execution of company programs remain consistent with the overall company values. The ideal candidate has a solid understanding of Manufacturing processes and general equipment and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.

Position Summary/ Objectives

The Equipment Engineer II will be responsible for supporting the manufacturing operations and validation activities with the goal of continuously improving safety, productivity, yields, process reliability and manufacturing costs. This position ensures that the solid execution of company programs remain consistent with the overall company values. The ideal candidate has a solid understanding of Manufacturing processes and general equipment and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.

Essential Job Functions:

• Perform commissioning and qualification of new equipment
• Preparation and review of equipment qualification reports
• Write or revise standard operating procedures.
• Participate in new equipment design, selection, startup and optimization
• Troubleshoot equipment performance issues including identification of root cause and prevention of reoccurrence
• Work with R&D and other personnel to transfer new equipment into manufacturing.
• Evaluate manufacturing processes and develop proposals to either correct identified problems or for process improvements.
• Work independently or in support of other engineers/scientists in solving problems.
• Improve overall equipment reliability for the Company’s manufacturing operations
• Troubleshoot and optimize the existing packaging and filling equipment to improve throughput and cost efficiency
• Program software and perform software validation on various types of equipment
• Manage large scale equipment projects independently and working with a team

Competencies:

• Meaningful Innovation
• Ownership/Accountability
• Pace/Efficiency
• Teamwork/Collaboration
• Integrity/Ethical Practice
• Resilience/Grit

Physical Demands

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. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 50 pounds.

Education, Experience and Certification:

• Bachelors’ degree in Mechanical Engineering or equivalent
• 610 years of industry experience
• Experience in a regulated industry, including work in the Medical Device, Pharmaceutical or an ISO 9000+ registered company or similar
• Experience with Microsoft software applications (Word, Excel, Power Point)
• Strong writing skills and ability to perform detailed document review
• Ability to manage change and grasp new concepts/processes quickly
• Excellent verbal and written communication and ability to work in a team environment
• Handson startup and troubleshooting skills
• Selfstarter; ability to work with minimal supervision

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Other Duties As Required

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Total Rewards & Benefits:

Regenity offers a comprehensive rewards package, including:

• Company performance bonus eligibility
• 401(k) plan with company contribution
• Paid time off and paid holidays
• Medical, prescription, dental, and vision insurance
• Companypaid life and AD&D insurance
• Wellness Program and Employee Assistance Program (EAP)
• Tuition Reimbursement

Salary Range: $85,000-$105,000

Regenity Biociences, Inc. is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. Regenity celebrates the diversity of our team. We believe that talent, drive, and experience are the only relevant criteria for considering new team members.