Process Engineer, Manufacturing Science & Technology (MSAT) 503B - Empower Pharmacy

Position Summary:

In our company, the role of Process Engineer in optimizing manufacturing processes to produce sterile finished commercial products is pivotal. This position plays a crucial part in ensuring that our production processes meet the highest standards of quality and innovation. By focusing on isolation technologies and continuous improvement, this role directly supports our values of people, service, quality, and innovation, ensuring that Empower consistently delivers exceptional products to our customers.

You will be at the forefront of designing and implementing process improvements to enhance product quality, yield, and efficiency. Collaborating with cross-functional teams, including manufacturing and quality assurance, you will support commercial manufacturing activities and lead investigations into process non-conformances. Your efforts in identifying root causes and implementing corrective and preventive actions will be vital in maintaining our high standards. Additionally, you will participate in technology transfer activities, ensuring the smooth transition of processes from development to manufacturing and within the Empower network.

Your contributions will extend to developing and managing process documentation, providing technical support, and training to manufacturing personnel, and optimizing sterilization, depyrogenation, and cleaning processes. By conducting studies and risk assessments, you will identify potential hazards and mitigation strategies, ensuring that our manufacturing processes comply with industry standards and regulatory requirements. Your role will involve troubleshooting equipment, analyzing process data, and driving continuous improvement initiatives to maintain the efficiency and reliability of our operations.

Join us in our mission to produce innovative medications that help people live healthier, happier lives. At Empower, you will have the opportunity to make a meaningful impact by expanding access to quality, affordable medication. If you are passionate about driving process excellence and ensuring the highest standards in pharmaceutical manufacturing, we invite you to apply and become a part of our dedicated team.

Duties and Responsibilities:

• Optimizes manufacturing processes to produce sterile finished commercial products, including upstream and downstream processes while focusing on isolation technologies.
• Designs and implements process improvements to enhance product quality, yield, and efficiency.
• Performs process risk assessments and implements Corrective Actions / Preventative Actions (CAPAs) to minimize risk.
• Collaborates with cross-functional teams, including manufacturing and quality assurance to support product commercial manufacturing activities.
• Leads investigations into process non-conformances, identifies root causes and implements corrective and preventive actions.
• Participates in technology transfer activities to ensure smooth transfer of processes from development to manufacturing and within the Empower network.
• Develops process documentation such as Standard Operating Procedures (SOPs), Work Instructions, protocols, and other similar Current Good Manufacturing Practice (cGMP) documents.
• Provides technical support, oversight, and training to manufacturing personnel to ensure proper execution of manufacturing processes.
• Contributes to the design and qualification of manufacturing equipment, new product development, tech transfer strategies, and overall, Right First-Time initiatives.
• Optimizes sterilization, depyrogenation, cleaning, and conversion processes based on technical challenges, regulatory constraints, and personal protective equipment limitations.
• Conducts studies and risk assessments to identify potential hazards and mitigation strategies.
• Utilizes cross-functional collaboration, including research and development, quality assurance, and manufacturing, to integrate sterilization processes into product development and production.
• Performs troubleshooting of sterilization equipment and processes to ensure efficient operation and minimal downtime.
• Analyzes process data to identify trends, optimize performance, and drive continuous improvement initiatives.
• Brings technical expertise to support and ensure compliance with industry standards and regulatory requirements, such as the Food and Drug Administration (FDA), Internal Organization for Standardization (ISO), and cGMP.
• Participates in validation processes, including protocols for installation qualification, operational qualification, and performance qualification, to ensure the reliability and effectiveness of sterilization processes.
• Participates, manages, and guides document control, creation, and issuance to ensure SOP’s and other guidance documents are correct, clear, concise and provide guidance to Sterile Manufacturing Operators are successful.
• Creates reports, graphs, and charts, and providing technical support and Executive Leadership Team and Senior Leadership Team presentations.
• Other duties as assigned.

 

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 in order 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.

Knowledge and Skills:

• Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.
• Sound understanding of aseptic processing requirements, cGMP’s for Aseptic manufacturing, filtration, and filling, etc.
• In-depth understanding of chemical processes, materials science, thermodynamics, and fluid mechanics.
• Familiarity with FDA regulations, cGMP, ISO, and drug products.
• Understanding of quality control analysis and the process parameters associated with analytical testing results and in-process testing is a plus.
• Understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human stability requirements.
• Ability to develop and review operations standards procedures.
• Ability to communicate clearly and quickly technical issues to both technical and non-technical support groups.

 

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 others accountable to meet commitments and objectives.
• 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.

 

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

Experience and Qualifications:

• Bachelor of Science in Chemical Engineering, Chemistry, Pharmaceutics, Pharmaceutical Science, or another related field.
• Minimum of five years working as an engineer; managing the drug product conversion in an aseptic environment is highly desirable.
• Master of Science degree with 2-3 years of direct process engineering experience may be considered.
• Experience with Liquid (Injectable) dosage form mixing, weighing, fluid flow, filtration & filling, sterilization, lyophilization and other fundamentals of liquid production is a plus.
• Experience with Failure Mode and Effects Analysis, engineering support, CAPA, and new product development/introduction.

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.