Automation Engineer 503B - Empower Pharmacy

Position Summary:

The Automation Engineer plays a pivotal role in advancing the operational efficiency and innovation at Empower, ensuring our automated systems are reliable, precise, and aligned with the highest standards of quality and compliance. This role is integral in optimizing and troubleshooting a diverse range of automated equipment, from manufacturing to facility management systems, supporting our mission to deliver high-quality medications efficiently and effectively. By maintaining and enhancing our automation infrastructure, you will contribute to a seamless production process that upholds our values of service, quality, and
innovation.

This position requires a dynamic and skilled professional who can navigate complex control systems, providing on-call support and troubleshooting to keep our automated processes running smoothly. You will lead programming, qualification, and validation efforts for digital process automation systems, and play a key role in implementing modern technologies and equipment. By ensuring compliance with current Good Manufacturing Practices (cGMP) and Good Automated Manufacturing Practice (GAMP) standards, you will help maintain the integrity of our production environment, driving continuous improvement and innovation.

 

Collaboration is at the core of this role. You will work closely with various departments, coordinating the integration of new equipment and automation technologies while providing expert guidance during regulatory inspections. Your technical expertise will be invaluable in developing maintenance plans, resolving complex issues, and training new team members to build a culture of excellence and innovation.

 

If you are passionate about driving operational excellence through advanced automation and contributing to a meaningful mission, we invite you to apply and become part of a team dedicated to producing innovative medications that help people live healthier, happier lives. Join us in expanding access to quality, affordable medication and making a real difference in the
world.

Duties and Responsibilities:

• Troubleshoots control systems in coordination with the original equipment manufacturer to automate processing equipment, including vial washing machines, tunnels, filling, isolators, lyophilizers, autoclaves, mixing vessels, packaging lines, laboratory equipment, facility systems, stability chambers, building management systems, clean in place and steam in place systems, water system controls, and vision systems.
• Performs programming, qualification, and validation of digital process automation systems.
• Provides 24/7 on-call automation support, including technical support and troubleshooting functions.
• Performs formal systems acceptance testing, including software simulation and hardware and equipment acceptance in pharmaceutical manufacturing facilities.
• Properly completes documentation for accurate recordkeeping, according to the Engineering Department's procedures, and assists with updating departmental procedures.
• Monitors equipment to ensure preventative maintenance is performed and manages calibration monitoring and engineering analysis.
• Ensures compliance with cGMP and GAMP standards for instrumentation, automation, business, and control systems for full facility equipment, building management systems, and environmental monitoring systems.
• Assists with training coworkers on equipment usage.
• Reads, understands, verifies, and develops piping and instrumentation diagrams, engineering layouts, drawings, and documents.
• Provides subject matter expertise for regulatory inspections and interacts with auditors, as necessary.
• Gowns into classified cleanroom within 15 minutes of an issue being reported.
• Implements projects according to GAMP guidelines for the validation of automated systems in pharmaceutical manufacturing.
• Coordinates with various departments on bringing in new process and manufacturing equipment, including validation, automation, and quality assurance.
• Generates engineering and manufacturing process documents and checks engineering drawings for accuracy and logic.
• Troubleshoots and updates programmable logic controller (PLC) software as needed.
• Assists in writing operating procedures and validation procedures for manufacturing
  equipment.
• Performs validations for manufacturing equipment, including generating and recording engineering data and results.
• Participates in the design and installation of new manufacturing equipment.
• Supports the manufacturing team in solving complex problems and implementing engineering upgrades and installations for manufacturing and process control equipment.
• Develops equipment maintenance plans based on failure modes and effects analysis and quickly responds to downtime issues, serving as the first responder to downtime events.
• Serves as the workflow coordinator, providing guidance through urgent production issues, triaging issues, and fielding technical questions to management regarding breakdowns and other equipment issues.
• Assists with the training and orientation of new department team members.
• Performs preventative maintenance duties as assigned.
• Assists with all aspects of new equipment installation.
• Seeks out and implements potential process or system improvements in primary and other functional areas.
• Leads cross functional process teams in projects focusing in primary functional area.
• Contributes to cross functional teams in projects focusing on other functional areas.
• Performs 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:

• A working knowledge of PLC Systems such as Allen Bradley, Schneider, and High-Level language Programming such as C#, VB.net, structured query language server is desired.
• Practical knowledge of automatic injectable filling line equipment (upstream and downstream).
• Broad and in-depth knowledge and practical experience of computer and application validation (preferably using GAMP methodology), cGMP, and 21 Code of Federal Regulation Part 11 in a Food and Drug Administration regulated environment.
• Ability to use basic hand and power tools/equipment: such as hand drill, forklift, and scissor lift.
• Ability to read electrical schematics and mechanical drawings.
• Ability to research parts, drawings, diagrams, and schematics.
• Ability to identify, maintain, and troubleshoot motor controls including motor starters, variable frequency drives, direct current drives, and standard electrical components and advanced automation controls systems.
• High capability to work in and maintain cleanliness in manufacturing areas.
• Ability to discern and recommend best solution among multiple alternatives using information at hand and engineering judgment.

 

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’s degree in Automation Engineering, Electrical Engineering, or related field.
• Minimum 5 years of experience in pharmaceutical documentation and engineering related activities combined.
• Experience in Automation/Technical role in high volume manufacturing environment preferred.
• Experience with computerized maintenance management systems.
• Experience with Microsoft Office 365.

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.