Empower is a dynamic and fast growing FDA registered 503A Compounding Pharmacy and 503B Outsourcing Facility based in Houston, Texas. We take immense pride in providing our patients with a broad list of health and wellness products to improve their quality of life. Empower is focused on delivering the finest quality healthcare products at competitive prices by disrupting the antiquated pharmaceutical model. We believe in providing world class customer service and delivery processes to our patients, while ensuring their safety through investing in our people and the latest technologies.
Our leadership understands that the basis of a great company is our people. Our diverse culture is akin to a fast-paced Silicon Valley startup and is the foundation for the company’s broader perspective, to serve the needs of our patients through innovation. Empower is in search of bright, self-motivated professionals who are focused, open-minded, and hard-working. This is your opportunity to be part of a company and culture that will appreciate and leverage your unique talents to make a difference in the lives of our patients.
The Equipment Engineer is responsible for seeking, commissioning, qualifying and validating equipment that is used in manufacturing operations. She/he ensures equipment utilized in Sterile and Non-sterile manufacturing are qualified for use and trains personnel as needed. She/he seeks provides production optimization support, process evaluation/qualification, and operates production equipment as needed. She/he leads the device and material design in support for sterile and non-sterile manufacturing operations. She/he provides engineering support as needed for all aspects within Facilities and Engineering and R&D.
- Ensures that all facility equipment processes are qualified and validated as required per current Good Manufacturing Practices (cGMP)
- Creates URS, DQ, IQ, and OQ protocols for new equipment
- Implements IQ, OQ, PQ and CQ Protocols
- Performs and documents qualification protocols simultaneously for various forms of machinery and processes
- Provides engineering support for single use systems
- Accountable for calibration of equipment
- Creates PM programs for equipment
- Joint responsibility in equipment functionality with facilities department
- 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 and perform 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 change control processes
- Works with operational department to perform quality investigations in timely manner regarding deviations, out of tolerance conditions, unexpected results on facility and equipment 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
- Manages external contractors and vendors, as required
Education and Experience
- Bachelor's of Science Degree in Chemistry, Engineering, Microbiology, or a related field, plus 4 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, de-pyrogenation, wet steam and dry heat sterilization and packaging.
- Demonstrated experience and knowledge of qualifying changes to validated systems/processes/and equipment.
- 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 on parenteral solutions and regulatory requirements as they relate to IQ/OQ/PQ/VQ’s.
- Ability to operate machinery such as clean steam generator, autoclave, and lyophilizer
- Flexible Spending Account (FSA)
- Health Savings Account (HSA)
- Prescription Services
- 401(k) with company matching
- Paid Time Off (PTO)
- Paid Holidays
- Potential for career growth within an expanding team and organization