Engineering Manager
Amneal Chicago, Illinois, United States · $120K–$150K/yr
Pharmaceutical Manufacturing · 5,001-10,000 employees
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About the role
The Engineering Manager is responsible for directing developmental engineering functions, managing plant equipment, and ensuring compliance with FDA and EU regulations. They oversee personnel, manage engineering projects, and implement Lean Manufacturing methodologies to support business objectives.
What they look for
Requirements
Candidates must hold a Bachelor of Science degree in Engineering and have at least 3 years of supervisory experience in a biotech, pharmaceutical, or medical device setting. Proficiency in technical problem-solving, project management, and regulatory compliance is required.
Benefits
Full description
The Engineering Manager, at Kashiv BioSciences, LLC, in Chicago, IL, is responsible for managing and supervising several departments within the engineering function of the company. Essential duties:
- Comply with all company policies and standards.
- Plan, direct, and implement the organization's developmental engineering functions, which may include:• Reliability standards pertaining to materials and techniques used in design and production.
- Mechanical systems and equipment activities.
- Research and technical design activities responsible for designing, developing, modifying, and evaluating electronic parts, components, integrated circuitry, and other hardware systems.
- Ensure all processes minimize health and safety risks.
- Develop and maintain the Engineering Change System.
- Maintain responsibility for the plant's current footprint and understand future footprint requirements based on business needs.
- Determine preventive maintenance standards for new equipment.
- Plan, direct, document, and analyze periodic preventive maintenance activities.
- Maintain and update drawings and specifications for all equipment.
- Research and implement cost-effective upgrades to equipment and facilities.
- Manage Lean Manufacturing methodologies for current, new, and transferred programs.
- Recommend and initiate modifications or replacement of equipment that fails to meet operating standards.
- Participate in the Health, Safety, and Environmental (HSE) program by following all applicable policies, procedures, and work instructions, including safety rules, safety observation audits, regulatory compliance, environmental awareness initiatives, audits, and continuous improvement activities.
- Keep current with advances in control technology and safe work practices.
- Understand, manage, and maintain awareness of all equipment within Engineering, Manufacturing, Quality Control, and Microbiology laboratories.
- Manage feasibility studies to determine whether designs are capable of functioning as intended.
- Select, develop, and evaluate personnel to ensure the efficient operation of the engineering function. Provide guidance to subordinates within established company policies.
- Receive assignments in the form of objectives and determine how to effectively utilize resources to meet schedules and goals.
- Recommend changes to policies and establish operating procedures as needed.
- Frequently interact with management and employees across departments to resolve issues and support business objectives.
- Ensure compliance with FDA and EU regulations.
- Perform gap analyses and provide recommendations for existing qualifications.
- Demonstrate the ability to work effectively in a fast-paced, team-oriented environment.
- Apply technical problem-solving skills, manage multiple priorities, utilize logical and analytical reasoning, demonstrate technical writing proficiency, and maintain the ability to self-train.
- Manage engineering projects from design through qualification, depending on experience and skill set.
- Perform other duties as assigned by management.
Qualifications
Education:
- Must have a Bachelor of Science degree in Engineering or related field.
- Masters of Science in Engineering or related field is a plus.
Experience:
- Must have at least 3 years of experience in a biotech, pharmaceutical or medical device setting. Project management is a plus.
- Must have at least 3 years of supervisory experience in biotech, pharmaceutical or medical device setting.
- 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.
Occasional trips for equipment FATs at vendor sites, or other business needs (lasting up to 2 weeks at a time). Potential for international travel.
The salary range for this position ranges from $120,000 - $150,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws.
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