- The hours for this position are Monday - Friday in our Albany, Ohio facility.
- Develop and manage site validation plan.
- Ensures systems and processes are validated in a compliant manner in accordance with FDA, cGMP requirements.
- Primary responsibilities include validation protocol execution (IQ, OQ, PQ, CSV, & PV), data analysis and final report preparation for utilities, equipment, manufacturing process and instrumentation.
- Schedule, plan, manage and execute studies for cleaning verification and validation.
- Performs re-qualification of equipment and facilities as required.
- Participate in investigation and for deviations impacting quality, safety, and productivity requirements.
- Collaborate, provide input, and develop validation strategies for various site transfer projects.
- Closely work with the facility to complete new equipment installation, commission, and validation as per project requirement.
- Supervise external resources for completion of critical tasks.
- Author, review and approve validation documents and SOPs.
- Lead and coordinate cross-functional teams for project validation.
- Prioritize, manage, and execute multiple projects utilizing the project management methodologies.
- Support regulatory submissions and regulatory agency inspections whenever required.
- In depth understanding of validation concepts, change control processes, good documentation practices, validation requirements for pharmaceutical equipment, facilities, utilities such as Autoclave, HVAC, WFI, Mixers, Washers, Ovens, etc.
- Ability to take ownership and accountability for the Validation function across multiple fast paced projects.
- Computer System Validation (CSV) experience with process control and automation systems
- Experience with automation, commissioning, qualification of pharma utilities, equipment, and production processes in a cGMP environment.
- Direct experience developing validation master plans, protocols, and execution of protocols.
- Knowledge of current industry standards such as GAMP5 and ASTM E2500.
- Excellent writing skills and ability to perform statistical analysis.
- Obtained a bachelor's degree in life sciences or engineering
- Gained at least 5 years of validation experience in pharma manufacturing operations
- Solid understanding of cGMP requirements as they pertain to validation of manufacturing and lab equipment in a pharmaceutical environment.
- A comprehensive benefits package that includes health, dental, and flexible spending accounts
- 401(k) retirement plan with a generous company contribution to help you save for the future
- Company Paid Life and disability insurance
- Access to voluntary insurance options
- A generous paid time off program that increases every year
- Tuition reimbursement
- Opportunity for growth - We believe in promoting from within and do so through our internal job posting program
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Validation Engineer - Albany, United States - Wedgewood
Description
Job DetailsLevel
Experienced
Job Location
Albany - Albany, OH
Position Type
Full Time
Education Level
4 Year Degree
Job Category
Pharmaceutical
Description
Great Care, Delivered is the promise that we make to our customers. If you have a passion for helping animals, and a love for serving others - we want you to help us deliver on that promise by joining our Quality Team.
This position reports directly to the Quality Director. The role is responsible for site validation plan, evaluating and validating the equipment and procedures used in development and production of a variety of products. Additionally, this role ensures all systems are running according to necessary specifications and operates within regulations to ensure the production of quality products for the Company's 503B cGMP manufacturing facility.
When will you work?
Wedgewood is the nation's largest and most trusted provider of compounded veterinary medications. Its recent merger with Blue Rabbit enables the company to provide veterinarians with next-generation software to streamline patient care and marks a significant evolution in services. Together Blue Rabbit and Wedgewood serve more than 70,000 veterinary professionals and one million animals annually.
Wedgewood is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. If you require an accommodation due to a special need or disability, please let your recruiter know what accommodations you will need.
