Validation Engineer

 
Empower Pharmacy has become a pioneer in the pharmaceutical industry by providing high-quality compounded sterile preparations that serve patients and healthcare providers. Our brand new 15,000 sq ft manufacturing facility located in Houston, Texas, is licensed with the Food and Drug Administration (FDA) as an Outsourcing Facility to provide high-quality sterile preparations nationwide.
 
With an uncompromising dedication to quality, we compound medications in a state-of-the-art facility that surpasses industry standards. Empower Pharmacy’s service is focused on the daily compounding/admixing, dispensing, and delivery of a variety of medications with uniquely trained and licensed pharmacy personnel compounding a broad range of patient and non-patient specific drugs.
 
We are looking for positive, upbeat, and enthusiastic people with strict attention to detail, analytical skills and a pleasant demeanor. Quality, dependable people with a strong work ethic and a teamwork approach. You'll have a healthy work-life balance and enjoy a working with a collaborative team. With a true quality mindset, Empower Pharmacy offers the opportunity to put your footprint on something you can be proud of.
 
Validation Engineer
 
Responsibilities:
 
The Validation Engineer is responsible for seeking, commissioning, qualifying and validating equipment and processes that are used in manufacturing operations. The validations and operations engineer ensures equipment and processes are validated and trains personnel as needed. The validation and operations engineer provides production optimization support and operates production equipment as needed

  • Ensures that all facility equipment processes are qualified and validated as required per current Good Manufacturing Practices (cGMP)
  • Creates DQ, IQ, OQ, and PQ protocols
  • Performs qualification protocols simultaneously for various forms of machinery and processes
  •  Creates, performs and completes validation projects simultaneously for various forms of machinery and processes
  • Operates thermal mapping equipment
  • Writes protocols for manufacturing, utility and lab equipment and processes related to machines qualified and processes validated.
  • Writes, reviews, and approves technical documents and reports such as protocols, SOPs, filing documentation and other cGMP documents
  • Trains personnel to operate validated machinery/processes
  • Coordinates validation activities with other departments to ensure validation projects are carried out on time and on budget
  • Designs and attends F.A.T. testing at vendor facility, as required. Manages and performs S.A.T.
  • Seeks out and commissions new machinery to increase efficiency and production
  • Implements changes for improving manufacturing efficiency and output performance by creating and utilizing management of change processes
  • Works with operational department to perform quality investigations in timely manner regarding deviations, out of tolerance conditions, unexpected results on facility issues by conducting failure analysis, root cause determination, and corrective action determination
  • Drives continuous improvement by managing projects and recommending techniques to enhance equipment/system/process robustness
  • Provides engineering support for product development for R&D when needed
  • Provides engineering support to facilities when specifying new equipment
  • Performs packaging engineering roles and responsibilities
  • Performs lyophilization cycle development
  • Operates machinery such as clean steam generator, autoclave, and lyophilizer for production/ operational support
  • Manages external contractors and vendors

EDUCATION AND EXPERIENCE:

  • Bachelor's of Science Degree in Chemistry, Engineering, Microbiology, or a related field, plus 2 years’ experience in the pharmaceutical industry, or equivalent experience.
  • Demonstrated experience validating a wide range of equipment and processes (including cleaning processes), including mixing, sterile fill, freeze drying, parts washers, vial washers, depyrogenation, wet steam and dry heat sterilization and packaging.
  • Demonstrate experience and knowledge of qualifying changes to validated systems/processes/and equipment.
JOB PREREQUISITES:
  • Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
  • Previous experience in the pharmaceutical industry with a manufacturing background.
  • Advanced knowledge of cGMP’s and regulatory requirements as they relate to IQ/OQ/PQ/VQ’s.

Benefits:

Group Insurance
  •  Medical Insurane
  •  Dental Insurance
  • Vision Insurance
  • Prescription Services
401(k) Program
  •  Company matching contributions
Paid Time Off
  • Paid holidays - 6 days
  • Paid Vacation (Initially) - 2 weeks
  • Paid Vacation (5 years of service) - 3 weeks
  • Paid Vacation (10 years of service or more) - 4 weeks
  • Personal and Sick Leave
  • Extended Sick Leave
  • Bereavement
Extended Time Off
  • Family Medical Leave
  • Disability & Maternal Leave
  • Military Leave
  • Jury Duty
Job Type: Full-time

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