Associate Production Engineer

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com.

The Associate Production Engineer is responsible for supporting the aseptic manufacture of Cresilon’s products. The Associate Production Engineer will be trained in clean room operations, aseptic techniques and must demonstrate the ability to successfully pass gowning qualifications. They will manage projects, author and revise standard operating procedures, work instructions, and investigations, and be required to support production of product. The Associate Production Engineer will collaborate with SMEs from Manufacturing, Quality, and R&D to improve processes as a liaison for Production Technicians on the floor. The ideal candidate will understand statistical process control (SPC) and use SPC and quality data to make data driven decisions when diagnosing, trouble shooting, and improving issues while maintaining frequent communications with Operations, Quality, and other teams as required.

Responsibilities:

· Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, and material handling while ensuring alignment with regulations

· Analyze and plan workforce utilization, space and workflow requirements, and design layout of equipment and workspace for maximum efficiency

· Manage supply inventory to ensure schedule adherence to the manufacturing plan

· Track KPI’s to identify opportunities to improve process efficiencies

· Contribute and/or lead LEAN projects within the Production Team (5s, Kaizen, etc).

· Provide feedback to Process Engineers regarding equipment design concepts and specification requirements to best align with manufacturing techniques

· Support manufacturing production with all required technical needs

· Operate production, assembly, and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling equipment, and packaging equipment

· Formulate, fill, and pouch product in accordance with SOPs

· Troubleshoot all operating deviations and issues and coordinate with other functions when required

· Report both machine and operating deviations to area supervisor or designee

· Perform routine, preventative maintenance on equipment

· Perform visual inspection of components and/or product in accordance with SOPs and cGMPs

· Oversee completion of Batch records and ensure compliance

· Utilize Fishbowl for all aspects of manufactruing

· Perform sampling, intermediate, and finished goods packaging as per SOPs

· Package and ship raw materials for sterilization

· Transport samples, materials, and equipment between multiple facilities

· Complete data entry and generate reports for material inventory movements

· Complete and maintain applicable logbooks and batch paperwork as required and in accordance with GMP and GDP standards

· Report all actual, near misses, and potential accidents for further investigation

· Take immediate action to resolve and near miss situations

· Assist in investigation of all actual, near miss and potential accidents. Provide information to troubleshoot and take initiative to resolve operational issues independently

· Assist in project commissioning and validation activities as necessary

· Prepare samples or prototypes as required for testing or other evaluations

· Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing processes

· Complete all required trainings: Read and Understand (TM1), Computer Based Training with Quiz (TM2), Instructor led (TM3/TM4), and On-The-Job Trainings (TM5).

· Oversee training of junior employees and Production Technicians on production processes as assigned

· Ensure proper communication and handling over of shift duties

· Support Environmental and Personal Monitoring (EM/PM) activities as needed

· Responsibilities may include other duties as assigned

Requirements

Education: Bachelor’s degree in Engineering with 0-2+ years of relevant experience in the pharmaceutical, biotechnology, or medical device industry

Physical Requirements:

· Ability to climb, balance, stoop, reach, stand and walk

· Ability to bend, twist, push lift and grasp

· Ability to speak, listen, and understand verbal and written communication

· Ability to pass respirator fit test

· Ability to work for extended periods of time with appropriate respiratory equipment

· Manual dexterity to perform delicate manipulations

· Ability to perform repetitive motions, including substantial movements of wrists, hands, and or fingers

· Ability to lift up to 50 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects

· Visual acuity to perform close activities such as: reading, writing, and analyzing; and to determine the accuracy, neatness, and thoroughness of work assigned or to make general observations

Preferred Qualifications:

· Master’s Degree with a background in Mechanical or Chemical Engineering

· Experience in GMP, ISO, and FDA regulated environments

· Cleanroom experience (ISO Class 5 to 8)

· Mechanical aptitude, with prior experience in troubleshooting and repairing mechanical and/or electrical equipment

Benefits

Paid Vacation, Sick, & Holidays

· Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

· Company Paid Life and Short-Term Disability Coverage

· Work/Life Employee Assistance Program

· 401(k) & Roth Retirement Savings Plan with company match up to 5%

· Monthly MetroCard Reimbursement

The Salary Range for this role is $55,000-70,000

Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.