Validation Engineer III - Houston, United States - Empower Pharmacy

Description

Company Overview

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation.

We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.

What sets us apart is our relentless focus on three core values: People, Quality and Service.

Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare.

Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you.

Here, you'll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference.

We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let's revolutionize healthcare, together. Join us and be a part of something extraordinary.

Position Summary

Join us as we embark on a transformative journey at Empower Pharmacy, where we redefine the standards of pharmaceutical validation with passion, innovation, and unwavering dedication.

As our Validation Engineer III, you'll lead our most ambitious projects, from inception to fruition, ensuring that every facet of our GMP processes surpasses regulatory standards with no room for compromise.

But that's just the beginning.

You'll craft our validation protocols with meticulous precision, serving as the linchpin of our compliance efforts to align our systems flawlessly with regulatory requirements before they reach our end users.

But where the real excitement ignites is in your role as a catalyst for growth.

As a Senior Validation Engineer, you'll empower our team members through comprehensive training initiatives, guiding them to new levels of success with your mentorship and leadership.

And there's more.

You'll orchestrate seamless coordination, overseeing CQV activities and leading technical transfers between sites and client locations to ensure unparalleled quality every step of the way.

When regulatory audits arise, you'll stand as our first line of defense, collaborating closely with our Validation Director to prepare and coordinate responses, upholding our unwavering commitment to excellence across all operations.

Join us on this exhilarating journey where every challenge is an opportunity, and every triumph is a testament to our collective dedication to setting new standards of excellence for Empower Pharmacy and beyond.

Duties and Responsibilities

Ensures that all facilities, utilities, equipment, computer systems and processes are qualified and validated as required per current regulations.

Authors, reviews, and approves commissioning, qualification and validation deliverables (URS, FAT, SAT, TOP, DQ, IQ, OQ, PQ, PPQ, CSV and PV (cleaning, sterilization) for facilities, utilities, equipment, computerized systems, Laboratory Instruments and processes related to compounding of sterile and non-sterile injectables.

Executes and completes qualification protocols simultaneously for various forms of equipment, systems, and processes.
Evaluates data obtained during CQV execution and authors Summary Reports.
Authors, reviews, and approves Exceptional Conditions or Deviations generated during CQV execution.
Uses project management tools to manage and track CQV and Technical Transfer projects.

Coordinates validation activities with other departments to ensure commissioning, qualification and validation projects are carried out on time and within budget.

Attends FAT testing at vendor facility, as required. Executes, performs, and summarizes SAT.
Completes change control impact assessments for new systems or changes to existing systems and processes.
Leads technical transfer activities between Empower sites and client sites.
Provides support for product development for R&D when needed.

Provide technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control.

Drives continuous improvement by managing projects and recommending techniques to enhance equipment/system/process robustness, improving manufacturing efficiency and output performance.

Authors, reviews, and approves technical documents and reports such as SOPs, forms, work instructions, filing documentation, and other cGMP documents.

Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, Impact Assessments, and other Quality Systems.

Works with other departments 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.

Trains personnel to operate equipment, perform sampling and execute processes.
Operates machinery such as clean steam generator, autoclave, depyrogenation oven, solids compounding equipment and lyophilizer for production/operational support.
Develops and performs lyophilization, and sterilization cycle development.
Develops cleaning validation and disinfectant studies as required.
Operates thermal mapping equipment.
Manages external contractors and vendors executing CQV activities for Empower.
Assists in Regulatory Audits.
Performs 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.
While performing the responsibilities of the job, the employee is required to talk and listen.

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.

The vision abilities required by this job include close vision.

Ability to walk, climb ladders, and carry test instruments to perform and assist in performance of protocol execution and equipment evaluations.

Knowledge and Skills

Advanced knowledge of cGMP and regulatory requirements related to Commissioning, Qualification and Validation.
Working knowledge of GAMP and 21CFR Part 11 compliance requirements.
Advanced knowledge of cleaning, sterilization, and computer systems validation.
Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations.
Excellent attention to detail.
Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.
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 of Science degree in a scientific or engineering discipline and a minimum of ten (10) years Validation experience in the pharmaceutical or biotechnology industries


OR
a non-science related Bachelor degree and a minimum 15 years of validation experience.
Project Management experience.
Computer System Validation experience a plus.
Certified Quality Engineer desirable.

Employee Benefits, Health, and Wellness

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.

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