Process Engineer II 503A - Houston, TX - Empower Pharmacy

Position Summary:

The role of Process Engineer II is crucial in maintaining Empower’s commitment to quality and innovation. This position ensures our aseptic filling and lyophilization operations run smoothly, minimizing downtime, and optimizing processes. Your expertise will directly impact our ability to deliver safe, effective, and reliable medications, aligning with our core values of people, service, quality, and innovation.

 

As a Process Engineer II, you will provide technical expertise and support for aseptic filling and lyophilization operations. You will develop and refine lyophilization process recipes, troubleshoot and repair lyophilizers, and utilize statistical methods to monitor process variation. Your ability to analyze data, identify trends, and implement process improvements will be essential in driving continuous improvement initiatives and ensuring optimized manufacturing operations.

 

Collaboration is key in this role. You will work closely with cross-functional teams, including manufacturing, quality, and validation, to develop and implement process improvements, ensuring compliance with regulatory requirements and industry best practices. You will also participate in process validation activities, support equipment qualification and commissioning, and perform risk assessments to minimize potential hazards.

 

We invite you to apply and become part of a team dedicated to producing innovative medications that help people live happier, healthier lives. At Empower, we are passionate about expanding access to quality, affordable medication, and we believe that every team member plays a vital role in achieving this mission. Join us and contribute to a company where your efforts truly make a difference.

Duties and Responsibilities:

• Provides technical expertise and support for aseptic filling and lyophilization operations, including process troubleshooting, optimization, improvement initiatives and minimizing downtime.
• Develops lyophilization process recipes, ensuring proper operation and reliability.
• Responsible for the proper equipment operation and troubleshooting of lyophilizer and effecting necessary repairs.
• Utilizes statistical methods to monitor and understand process variation routinely and recommend appropriate action based on trends.
• Performs data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues.
• Analyzes process data to identify trends, optimize performance, and drive continuous improvement initiatives.
• Prioritizes and implements process change requirements based on the critical project needs.
• Supports change management system for process changes and or new processes.
• Collaborates with cross-functional teams, including manufacturing, quality, and validation, to develop and implement process improvements, ensuring optimized and efficient manufacturing operations, as well as compliance with regulatory requirements and industry best practices.
• Participates in process validation activities, including protocol development, execution, and report writing.
• Supports equipment qualification and commissioning activities for new manufacturing equipment or processes.
• Maintains expertise as necessary to stay abreast of technical and industry advancements, and best practices related to aseptic processing.
• Performs process risk assessments and implements corrective and preventive actions to minimize risk.
• Develops process documentation such as standard operating procedures (SOPs), work instructions, protocols, and other similar good manufacturing practice (cGMP) documents.
• Conducts studies and risk assessments to identify potential hazards and mitigation strategies.
• Creates reports, graphs, and charts, and provides technical support to executive leadership team and senior leadership team presentations.
• Other duties as assigned.

 

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.

 

Must be able to Aseptically gown and perform in an ISO 5/ISO 7 Cleanroom environment. While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus.  The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Must be able to lift up to 10 pounds and carry, push, pull or otherwise move objects.

Knowledge and Skills:

• Strong knowledge of pharmaceutical processing principles, cGMP regulations, and regulatory requirements such as the Food and Drug Administration (FDA) and United States Pharmacopeia (USP).
• Proficient in data analysis and statistical tools for process monitoring and optimization.
• Excellent problem-solving and troubleshooting skills, with the ability to identify root causes and implement effective corrective actions.
• Keen eye for detail and the ability to conduct rigorous data analysis.
• Application of statistical methods to understand process variations and optimize performance.
• Ability to develop and review SOPs.
• Ability to communication clearly and quickly technical issues to both technical and non-technical support groups.
• Expertise in process engineering, root cause analysis, Failure Mode and Effects Analysis and equipment troubleshooting.
• Technical expertise in and support to ensure compliance with industry standards and regulatory requirements, such as the FDA, USP, International Organization for Standardization (ISO), and cGMP.

 

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions. 
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and other accountable to meet commitment.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Experience and Qualifications:

• Bachelor’s degree in chemical, Mechanical or Biomedical engineering, Pharmaceutical Sciences, or a related field.
• 5 years of experience in aseptic filling equipment and processes, such vial washer depyrogenation tunnel, filling machines and lyophilizer in the pharmaceutical industry.

Benefits:

• No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
• Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
• Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
• Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
• Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
• Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
• Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
• FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
• 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
• Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
• Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
• Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.

 

Additional Voluntary Benefits

• Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
• Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
• Critical Illness: Protect your finances from the expenses of a serious health issue.
• Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
• Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
• Legal Services: Access professional legal assistance to address concerns confidently.
• Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
• Pet Insurance: Care for your furry family members with our pet insurance coverage.
• Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.