Process Engineer - Bright Innovation Labs

• SUMMARY / OBJECTIVE

Responsible for the overall ownership and performance of the Validations for the Facility, including evaluating processes in Compounding and Production related to the batching and filling of any existing products or formulas under future development. This position will also be responsible for evaluating all the equipment related to the compounding, transferring, and filling of all products and making recommendations for equipment and processes to maintain product integrity and specifications throughout all manufacturing in order to reduce cost, improve sustainability, and develop best practices within the manufacturing process.

• ESSENTIAL FUNCTIONS include but are not limited to the following. Other duties may be assigned.

• Manage OTC Validation Program and Change Control Program including Process Validation and Equipment Validation, Maintenance of the completed validations.

• Responsible to perform Installation and Operation qualification of all equipment.

• Responsible for ensuring water system is compliant including validations of water system.

• Writing and executing Cleaning Validation protocols for different equipment according to 21 CFR Part 110 (cGMP in Manufacturing, Packing or Holding Human Food).

• Lead, design and execute all plant wide process scale-up activities from R&D scale through fully commercialized scale to assure compliance to product specification.

• Lead and direct training activities for Compounding and Quality Control Personnel in areas related to batch processing.

• Provide technical expertise for design and installation of new equipment and process related to batch manufacture.

• Performs research, evaluates, designs, and develops manufacturing processes including product flow, storage of products and assembly methods for the compounding and production equipment.

• Maintain reliable and safe manufacturing practices while improving batching reliability, mixing, and holding tank outages / yields, compounding rates and batching times, and wastewater costs.
• Improve process capability and production volume while maintaining and improving quality standards.
• Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
• Assist Plant Manager and Department managers in improving systems related to compounding and production control. Create, evaluate, and update all standard operating procedures for processes, equipment, quality, and safety related to the area of responsibilities.
• Maintains product and company reputation by complying with federal and state regulations.
• Promote compliance with Bocchi Laboratories' policies, procedures, quality standards and current Good Manufacturing Practices (cGMP) as well as safety and environmental regulations. Participate, as required, in safety and GMP training sessions, and other company training sessions.

• COMPETENCIES: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Process Management, Manufacturing Methods & Procedures
• Lean Manufacturing techniques
• Strong planning ability
• Safety Management and Documentation Skills
• Strong knowledge in CAD, CAD/CAM Circuit Design
• Change agent with energy, passion, and enthusiasm to drive change
• Understands customer needs, industry trends, and the competitive landscape in the industry
• Ability to simplify strategy into specific action with clear accountability, making decisions with speed and accuracy based on best available information
• Capable of working effectively as part of a multifunctional team
• Must successfully pass a background check and drug screen
• Must have some background in project management
• SUPERVISORY RESPONSIBILITIES
• If needed, to carry out supervisory responsibilities (under the direction of Plant Manager) in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work.
• WORK ENVIRONMENT
  1. This position functions on the production floor and therefore, will experience characteristics commonly found in a manufacturing setting. Characteristics would include (but not limited to):
     1. frequently exposed to moving mechanical parts; occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually moderate.

• PHYSICAL DEMANDS
  1. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• POSITION TYPE/EXPECTED HOURS OF WORK
• This is a full-time position. The base days and hours are Monday through Friday, eight (8) hours per day depending on shift assigned.
• TRAVEL
  1. No travel is expected for this position.

• REQUIRED EDUCATION & EXPERIENCE

Bachelor's Degree in Process, Industrial, Chemical or Mechanical Engineering and 5 or more years' experience in Manufacturing with a background in plant layout, process development and manufacturing quality preferred.

• PREFERRED EDUCATION & EXPERIENCE LANGUAGE SKILLS

• LANGUAGE SKILLS
• Must have strong verbal, writing skills and communication skills. Must be able to speak, read, and write in English. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedure, or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.

• MATHEMATICAL SKILLS
• This position requires analytical and mathematical skills, quick thinking, and a solid understanding of the main principles of engineering.

• REASONING ABILITY:
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

• COMPUTER SKILLS
• Must have a high level of competency working with computers and programs.

• CERTIFICATES, LICENSES, REGISTRATIONS
• Professional Engineering Status or Engineering License required

• ADDITIONAL ELIGIBILITY QUALIFICATIONS
  1. English language and knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

• WORK AUTHORIZATION
  1. Must be authorized to work in the U.S. as a pre-condition of employment.

• EEO STATEMENT
  1. Bright Innovation Labs is an equal opportunity employer. Bright Innovation Labs does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.