Process Engineer II

Chemence Medical, Inc.; Alpharetta (GA); On-site; USD 70,000 - 80,000; Full time

Job summary

Chemence Medical, Inc. is seeking a skilled Process Engineer to lead the design and validation of chemical processes. The role involves conducting advanced engineering calculations, documentation, and participating in client meetings, ensuring compliance with ISO and GMP standards. With a focus on innovation and quality, this opportunity offers growth and substantial responsibilities in a dynamic environment.

Benefits

Medical insurance

Vision insurance

401(k)

Tuition assistance

Disability insurance

Qualifications

• Minimum of 5 years in chemical process engineering.
• Experience with validation processes and GMP standards.
• Ability to work in a fast-paced environment with multidisciplinary teams.

Responsibilities

• Lead the design and validation of chemical processes.
• Prepare detailed documentation and analysis results.
• Monitor vendor deliverables and maintain engineering standards.

Skills

Design Process Flow Diagrams

Process Equipment Sizing

Communication Skills

Time Management

Education

Bachelor’s in Chemical Engineering

Tools

PID Controllers

PLC's

Risk Assessments

Job description

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Summary:

The responsibility for this position includes performing advanced engineering calculations and analyses, and will take the lead position in the preparation, performance, and on-schedule completion of project work; participating in the Design of new Chemical Processes (small, medium and large scale) and Scale-up & Validation of Chemical Processes and accompanying test methods. Commissioning and qualification, and maintenance of the validated state of all direct impact chemical manufacturing systems for Medical GMP processes and ISO processes will be required. This is a position which will require detailed knowledge of chemical processes and experience in validating them.

Key Duties and Responsibilities:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Design Process Flow Diagrams, Material Balances, and Process & Instrumentation Diagrams.
• Size process equipment for distillation.
• Create functional (control) descriptions for all engineered systems.
• Provide analysis results in an effective form (written, marked up drawings, sketches, spreadsheets, presentation, as required) on work performed.
• Provide man-hour & material estimates for specific contract project tasks, and for entire internal projects.
• Participate in project team and client meetings, as needed.
• Monitor the work product of vendors, including schedule, budget, scope requirements, technical review and deliverables.
• Provide leadership and guidance in the preparation of Engineering Standards. Evaluate previous methodology and results to establish design factors, comparative values, and modify or create procedures.
• Participate in field assignments.
• Performs the necessary bench-scale reactions, purification, and solubility studies for the development of new chemical products or processes.
• Prepares transfer of technology documentation to support process development in production scale manufacturing.
• Assist with pilot scale manufacturing to support scale up of new manufacturing processes.
• Assists with developmental batches of new products in conjunction with manufacturing.
• Leads the Engineering aspects of IQ, OQ and PQ of new chemical processes and their hand-off to manufacturing staff.
• Other duties as assigned.

Qualifications, Education and/or Experience Required:

• Bachelor’s in Chemical Engineering with a minimum of 5+ years of Chemical process systems engineering experience. Prefer master’s in chemical engineering with a minimum of 5 years’ relevant experience.
• Knowledge of typical chemical manufacturing methods (distillation, reactive chemistry, scale-up
• Working knowledge of the setup and programming of process controls including PID controllers, instrumentation, transmitters, VFDs, PLC's
• Basic electrical knowledge of wiring requirements for temperature sensors, analog signals, communications cables, power hookups
• Thorough documentation skills to complete detailed safety and process transfer packages such as Risk Assessments and Standard Operating Procedures Process Validation, ISO13485, ISO9001
• Clear and effective communication skills. Must be able to work with internal customers to identify system requirements and summarize them in a clear and concise manner
• Ability to function effectively as a member of cross-functional, cross-disciplinary, and inter-corporate teams
• Effective prioritization and time management to meet project goals / milestones

Language Skills:

Physical Demands:

• Position requires walking, standing for prolonged periods, occasionally required to sit, climb, or balance, stoop, kneel, crouch or crawl. May frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 15 pounds.
• Non-temperature-controlled warehouse, non-temperature-controlled production floor, temperature-controlled office.

Other Duties:

• 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.

AAP/EEO Statement:

• CHEMENCE provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Tuition assistance

Disability insurance

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