Job Description

The Engineering Manager is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee is responsible for managing and supervising several departments within the engineering function of the company.

Essential Duties & Responsibilities:

• Complies with all company policies and standards.
• Plans, directs, and implements the organization's developmental engineering functions, which may include any of the following functions:
• Reliability standards pertaining to the materials and techniques used in design and production.
• Activities of mechanical systems and equipment function.
• Activities of a research or technical design function responsible for designing.
• Developing, modifying, and evaluating electronic parts, components or integrated circuitry for electronic equipment and other hardware systems.
• Ensure all processes prevent any health or safety risks.
• Develop and maintain the Engineering Change System.
• Responsible for the Plant's current footprint and understanding the Plant's future footprints according to business.
• Determine preventative maintenance standards on new equipment.
• Plan, direct and record periodic preventative maintenance and analysis of equipment.
• Maintain update drawing and specification on all equipment.
• Researches and implements cost effective upgrades to the equipment and facilities.
• Manage the Lean Manufacturing methodology with current, new or transferred programs.
• Recommends and initiates modification of replacement of equipment that fail to meet operating standards.
• Participates in the Health, Safety and Environmental program by following all policies, procedures and work instructions that may include safety rules, safety observation audits, regulatory compliance, environmental awareness and audits and Continuous Improvement.
• Research and implement cost effective upgrades to equipment and facilities.
• Keep abreast of the latest in control technology and safe work practices.
• Understands, manages, and keeps up to date on all equipment in the laboratories (ENG, MFG, QC and Micro)
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
• Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
• Provides guidance to subordinates within the latitude of established company policies.
• Recommends changes to policies and establishes procedures.
• Frequently interacts with management and employees of other departments to resolve issues.
• Often must lead a cooperative effort among members of a team.
• Manages, perhaps through subordinate supervisors, the coordination of the activities of the Engineering department with responsibility for results, including costs, methods, and staffing.
• Other duties as requested by management.
• Assure Compliance with FDA and EU Regulations.
• Assure all the routine and non-routine activities are tracked and successfully completed.
• Perform GAP analysis and provide recommendations for existing qualifications.
• Ability to work in a fast paced, team-oriented environment.
• Technical problem-solving ability, manage multiple priorities, provide logical and analytical reasoning, technical writing ability, and self-training.
• Manages engineering projects from design through qualification, depending on candidates experience and skill set.

Education:

• BS or MS Degree in related Engineering field.

Experience:

• At least 3 years of experience in a biotech, pharmaceutical or medical device setting is required, project management is a plus.
• 3-5 years supervisory experience in biotech, pharmaceutical or medical device setting is required.

Special Skills:

• Able to work in a fast-paced environment.
• Technical problem solving, handling multiple priorities, performing well under stressful situations, thinking fast, logical, and mathematical reasoning, technical reading interpretation and self-training.

Work Environment & Physical Demands:

• Work at a desk doing computer work (reading, editing, writing documents) is also required.
• Works in machinery rooms, clean rooms, and laboratories.

Noise:

• No extraordinary noise levels.

Standing/Lifting:

• Must be able to move around the facility to reach various equipment.
• Must be able to lift at least 25 lbs.

Visual:

• No special requirements

Stress:

• High paced demanding environment to meet ambitious project goals.

Travel:

• Occasional trips for equipment FATs at vendor sites, or other business needs (lasting up to 2 weeks at a time). Potential for international travel. No regularly scheduled travel.

Supervisory Responsibility, if any : Yes

Benefits/Perks:

• Medical
• Dental
• Vision
• 401K
• HSA/FSA
• Student Loan Assistance
• Monthly Cell Phone Allowance
• Free Parking (Company Paid)
• Conveniently located next to the Metra, Green and Red Line
• One block east of the Chicago White Sox Stadium
• < 10 minutes away from Downtown Chicago

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv Biosciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kashiv Biosciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

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