Quality Engineer/Validations Specialist

Full Time
Aurora, OH 44202
Posted
Job description

A little about our company:

Natural Essentials, Inc. was founded in 1995 as a family-owned business in Aurora, Ohio. Since then, the company has grown from humble beginnings into one of the nation’s top contract filling companies.

In 2010, the family launched Bulk Apothecary as a way to expand Natural Essentials. Originally a brick and mortar store in Streetsboro, Bulk Apothecary has also grown rapidly from its grassroots into one of the nation’s largest online retailers of natural ingredients, essential oils, soap making, and candle making supplies!

Our main focus at Bulk Apothecary is providing the best possible customer service by offering amazing products at great prices and working daily to improve our customers’ experience.

As a family-owned business, our owners ensure that our employees are able to spend as much time with their families as possible. Maintaining a healthy work-life balance is highly valued here. We only operate Monday-Friday so that parents have weekends with their children, provide amazing healthcare and benefits options for all types of families, and, through a team-oriented atmosphere, promote a positive work environment.

Employees in all departments have fun, work together, and get the job done!

Job Description:

The Validations Engineer/Specialist is responsible for performing complex validation and qualification activities for critical equipment, utilities, and processes. This position will need to travel frequently between the Manufacturing Facility and the Distribution Facility.

Duties and Responsibilities:

  • Writes and executes detailed validation/re-validation reports and protocols for both existing and new equipment, systems, and processes.
  • Compiles and analyzes and complex quality and statistical data to verify acceptable criteria for the product or equipment and to ensure completeness, accuracy, and compliance.
  • Plan, coordinate, and execute cleaning validation activities such as: cleaning studies, spray coverage testing, cleaning verification swabbing, rinse sampling, and maintenance of cleaning equipment.
  • Provide technical input for control strategies for the introduction of new products, as it relates to Cleaning Validation.
  • Maintains revalidation schedules ensuring the facility remains in a validated state.
  • Writes and reviews SOP’s related to quality activities.
  • Provide technical support/troubleshooting for process and equipment issues.
  • Attend production and team meetings, as required.
  • Coordinate with manufacturing and laboratory departments to assure effective communication on issues related to validation.
  • Investigate/resolve deviations associated with validation studies.
  • Author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
  • Perform periodic reviews and audits of equipment /systems/product matrix.
  • All other duties as assigned.

Required Knowledge, Skills, and Abilities:

  • Previous experience in a cosmetic/OTC manufacturing environment is required.
  • Detailed orientated, strong organization, and strong written and verbal communication skills; high level of personal/departmental accountability and responsibility.
  • Ability to manage multiple priorities and tasks in a dynamic environment.
  • Ability to exercise judgment to determine appropriate corrective actions.
  • Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Minimum of four (4) years of relevant manufacturing metrology, validation, or process engineering experience.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • Experience with Google Suite and Microsoft Office applications.
  • Bachelors Degree in Engineering or a related degree

Working conditions and Physical Effort:

  • Regularly able to lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds
  • Standing, sitting, or walking for more than 8 hours a day
  • Able to work in high heat and humidity or cold and dry conditions indoors/outdoors.
  • Full range of motion to lift, carry, walk, climb around equipment and facilities.
  • Work in elevated positions on ladders, lifts, and platforms.
  • Work involves moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises.
  • This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
  • Wearing PPE is necessary for the job.

Position reports to Director of Quality Assurance.

The hours for this position are 8:00 a.m. until 4:30 p.m., overtime may be required, and the hours may need to be adjusted during peak periods, or to meet the needs of the company in certain situations. This is a Salaried Exempt role, due to the nature of the position.

Hours: Monday-Friday from 8:00 am to 4:30 pm +/-

Salary: $65,000-$80,000/Year

Great benefits available - we offer medical coverage that has $0 deductibles, $0 co-pays, and many no cost prescriptions under the plan.

Natural Essentials, Inc. is an equal opportunity employer and shall not discriminate on the basis of race, color, religion, national origin, gender, age, sex, sexual orientation, gender identity or expression, marital status, mental or physical disability, and genetic information or any other basis protected by applicable law.

Job Type: Full-time

Pay: $65,000.00 - $80,000.00 per year

Benefits:

  • 401(k)
  • Dental insurance
  • Employee assistance program
  • Employee discount
  • Health insurance
  • Life insurance
  • Paid time off
  • Referral program
  • Vision insurance

Experience level:

  • 3 years

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Work setting:

  • In-person

Education:

  • Bachelor's (Required)

Experience:

  • Validations: 3 years (Required)

Work Location: In person

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