Remote Pharmaceutical Formulation Development Jobs in Indiana

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The Company

We build the machines that power industry. We are Hitachi Global Air Power, a leading global industrial compressed air manufacturer driving the innovations that keep the world moving.

From our headquarters in Michigan City, Indiana, our compressed air solutions power manufacturing operations all around the globe; from food and beverage to life-saving pharmaceuticals and cutting-edge semiconductor chips. Our portable compressors provide the air power to build roads and bridges, lay pipelines and aid in oil and gas mining and production.

We are a team of innovators, engineers, and quality experts with a shared vision to create the next generation of efficient, environment-forward compressed air solutions that meet the demands of today, while boldly contributing to a sustainable, circular economy. With more than 58 years of legacy and trusted performance through our brands - Hitachi, Sullair, and Champion (Australia), we are proud of our reputation for reliability, durability, and performance and groundbreaking engineering.

Join us in building a future where your work has an impact. At Hitachi Global Air Power, you'll be part of a global network that's shaping the future of industrial power.

Summary of the position:

The Product Compliance Engineer is responsible and accountable for ensuring that products are designed and manufactured in full compliance with all applicable directives, regulations, and legislative requirements, both domestic and international.

This position reports to the Director, Global Product Lifecyle Management, and will involve extensive cross-functional interaction, particularly with engineering, manufacturing, quality, sales, and marketing and at all stages of product development from research and pre-development through to post manufacturing support. The role involves being a key and influential member of the business with the prime focus of ensuring that current and future products are designed and manufactured in full compliance with applicable standards, directives, regulations, and legislative requirements.

This position is located on-site in Michigan City, Indiana.

Duties and responsibilities:

• Determine regulatory and compliance requirements of new products being developed and engineered orders based on where Hitachi Global Air Power intends to sell the products.
• Verify, review, and maintain all existing and emerging company and Government regulatory policies, standard work and procedures that have been documented, implemented, and communicated.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and standard work.
• Assist with and provide technical input into new product and component development for the purposes of ensuring compliance.
• Conduct product safety reviews.
• Work with engineering, manufacturing, and quality engineers to conduct periodic internal audits to ensure compliance with regulations and standard work.
• Conduct or direct the internal investigation of product compliance issues; identify compliance issues that require follow-up or further investigation.
• Provide sales support during customer meetings and visits when required.
• Provide technical writing and review of data or reports that will be incorporated into regulatory submissions to assure rigor, accuracy, and clarity.
• Review product promotional materials, labeling, specification sheets or test methods for compliance with applicable regulations and policies.
• File appropriate compliance reports with regulatory agencies.
• Report violations of compliance or regulatory standards to duly authorized enforcement agencies as appropriate or required.
• Prepare and present the Company's ability to ensure all controls are in place for all product lines.
• Oversee all product certification audits and shall work with other departments to ensure audit success.
• Responsible for working with third-party agencies and government agencies to ensure that products are being certified on time and on budget.

Qualifications:

Education:

• Bachelor's Degree in Mechanical Engineering or Electrical Engineering; Master's Degree a plus.

Professional experience:

• Minimum of 5-7 years of regulatory compliance experience preferred.
• International Regulation experience a plus.
• Ability to understand Hitachi Global Air Power Portable and Stationary compressor systems.
• Strong blueprint, P&I and Wiring Diagram reading capabilities.
• In-depth knowledge of compressor and other rotating equipment and their subsystems a plus.
• Ability to use relevant information and individual judgment to determine whether products or processes comply with laws, regulations, or standards.
• Must have a commercial appreciation with the ability to understand the importance of completing projects on time and to budget.
• Highly computer literate.
• Ability to compose accurate technical and general business documentation to a consistently high level.
• Ability to comfortably and effectively communicate at a high technical level, but also be capable of detailing and explaining complex information in non-technical terms.
• Attention to detail is essential as is a drive to perform tasks properly and thoroughly while adhering to Company guidelines, policies, and standard work.
• Experience on codes and standards development committees a plus.
• Experience as an Expert Witness a plus.
• Ability to work independently and as part of a team.
• Knowledge of the Engine driven machinery, Motor driven machinery, Canadian Registration Numbers (CRN), ASME codes, Third-party certification Agencies like UL, CSA, TUV SUD, TUV Rhineland. The Low Voltage Directive, the Pressure Equipment Directive, the EMC directive, Outdoor Noise Emission directive, and the Machinery Directives, EN 1012, The National Electrical Code, Engine Emission requirements for (US, Canada, Europe) etc.

Key behaviors:

• Attention to Detail: Regulatory compliance involves adhering to specific rules, standards, and guidelines. A compliance engineer must meticulously review and interpret these requirements to ensure the organization meets them accurately.

• Time Management and Organization: Managing compliance projects, deadlines, and reporting channels requires effective time management. Staying organized helps keep track of various tasks and ensures timely completion.
• Problem-Solving Skills: Compliance engineers encounter complex challenges related to legal frameworks, product design, and manufacturing. Being adept at problem-solving enables them to address issues efficiently.
• Effective Communication: Clear communication is crucial. Compliance engineers need to explain compliance protocols to stakeholders and authorities. They should also convey technical concepts effectively to colleagues and management.
• Technical Expertise: A solid technical background is essential. Understanding product/process design, regulatory frameworks, and industry-specific requirements allows compliance engineers to make informed decisions.
• Analytical Abilities: Analyzing compliance testing results, developments, and processes is part of the job. Strong analytical skills help identify areas for improvement and risk mitigation.
• Project Management: Compliance engineers often handle multiple projects simultaneously. Proficiency in project management ensures smooth execution of compliance-related tasks.
• Stay Updated: Regulatory landscapes evolve. Being aware of the latest developments, changes in standards, and industry trends is crucial for maintaining compliance.

Direct reports:

• N/A

The successful candidate is responsible for complying with Hitachi Global Air Power Code of Ethics and related policies. In performing the job, the incumbent shall take all steps necessary to comply with our safety policies and requirements and must actively support the organization's efforts to meet and exceed its goals of creating and maintaining a safe workplace.

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company's discretion.

Hitachi Global Air Power is an equal opportunity employer and will not discriminate based on race, religion, color, age, gender, sexual orientation, national origin, genetic information, veteran status, physical or mental disability, or other protected categories under applicable law, whether in recruitment, employment, promotion, transfer, compensation, or other conditions of employment.