Website Empower Pharmacy
Empower Pharmacy
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Company : Empower Pharmacy
Position Summary:
Join us as we revolutionize the world of pharmaceutical validation with passion, innovation, and an unwavering pursuit of excellence.
As a Validation Engineer I, you’ll lead the charge in ensuring the integrity and efficiency of our GMP processes. Your mission is to seek out, commission, qualify, and validate the very foundations of our operations, leaving no stone unturned in your quest for perfection, from cutting-edge computerized systems to state-of-the-art laboratory instruments.
But that’s just the beginning. You’ll be instrumental in training our personnel, equipping them with the knowledge and skills they need to excel. Your expertise will drive production optimization, fine-tuning our processes for peak efficiency and performance.
But where the excitement truly lies is in your role as the architect of our validation protocols. You’ll craft, execute, review, and summarize these critical documents with meticulous attention to detail, ensuring that we not only meet but exceed regulatory standards at every turn.
And that’s not all. You’ll orchestrate seamless coordination, overseeing CQV activities and supervising the work of external validation contractors and vendors. Your leadership will be crucial in propelling our validation initiatives forward, keeping us at the forefront of this ever-evolving industry.
Join us on this exhilarating journey where every challenge is an opportunity and every success is a triumph. Together, let’s push the boundaries of pharmaceutical validation and unlock new possibilities 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 Good Manufacturing Practices (cGMP).
Creates and reviews URS, DQ, IQ, OQ, PQ, CSV protocols.
Performs qualification protocols simultaneously for various forms of machinery and processes.
Completes validation projects simultaneously for multiple systems and processes.
Operates thermal mapping equipment.
Authors qualification and validation protocols for facilities, utilities, equipment, computerized systems, lab instruments and processes related to compounding of sterile and non-sterile injectables.
Writes, reviews, and approves technical documents and reports such as SOPs, forms, work instructions, filing documentation, and other cGMP documents.
Trains personnel to operate validated machinery/processes.
Coordinates validation activities with other departments to ensure commissioning, qualification and validation projects are carried out on time and on budget.
Attends FAT testing at vendor facility, as required. Executes, performs, and summarizes SAT.
Implements changes for improving manufacturing efficiency and output performance.
Completes change control impact assessments for new systems or changes to existing systems and processes.
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.
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.
Develops and performs lyophilization cycle development.
Operates machinery such as clean steam generator, autoclave, depyrogenation oven, solids compounding equipment and lyophilizer for production/operational support.
Manages external contractors and vendors executing CQV activities for Empower.
Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, Impact Assessments, and other Quality Systems.
Provide technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control.
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.
Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations.
Excellent attention to detail.
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 five (5) years Validation experience in the pharmaceutical or biotechnology industries OR a non-science related Bachelor degree and a minimum 8 years of validation experience.
Experience with cleaning and sterilization process validation.
Computer System Validation experience a plus.
Project Management experience a plus.
Certified Quality Engineer desirable.
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.