Associate Validation Engineer
Summary:
Position may perform the following: documentation, analytical assessment, or data gathering. The primary responsibility of this position is for support of qualification documentation filing, preparation or any responsibility surrounding data collection. Other department tasks may involve thermocouple assembly / calibration, data collection, system updates and other tasks as assigned.
Preferred excellent written and verbal communication skills, and ability to maintain cGMP compliance in accordance with worldwide guidance sources.
• Collects current equipment documentation to fill gaps or identify missing information. Working with Validation Engineers and quality assurance document control to implement necessary improvements. These may include modifications to existing documents, or collection and filing of current documents.
• Supports validation protocols for data collection, or creating documents, as assigned.
• Maintains compliance with regulatory agency guidance and company procedures.
• Assists with execution of equipment validation studies to include protocol execution, data analysis up to including control system administration such as software backups and system updates.
• Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Drafts commissioning and qualification protocols to sufficiently demonstrate the process is designed and fit for the intended use
• Supports on-going system requalification and continuous improvement activities governed by change management processes Skills:
• Possess an understanding of documentation organization, and ideally in a GMP environment
• Must have excellent verbal and written communication skills, attention to detail, and problem solving skills.
• Must be experienced with Microsoft Office tools, i.e. Word, Excel, etc.
• Desirable to also have some basic mechanical skills.
• Preferred understanding of statistical analysis tools and/ or analytical methods. Education/Experience:
• BS/BA Degree in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility.
• 0 - 2 years pharmaceutical manufacturing experience. Pay ranges between $20-24.60/hr based on experience
Recommended Jobs
Licensed Board Certified Behavioral Analyst - BCBA
Job Description Job Description Job Title: Licensed Board Certified Behavioral Analyst Department: Clinical Reports to: Clinical Director Compensation: $95,000-$127,500 annually, base…
Bilingual Porter Supervisor
Job Description Job Description SUPERVISOR JOB DESCRIPTION JOB SUMMARY As a supervisor, you will be responsible to effectively direct, manage, train and re-train the team as needed and mana…
Assistant Store Manager
Swatch is seeking an Assistant Store Manager for its Times Square location in New York. This role involves supporting the Store Manager in overseeing store operations, ensuring customer satisfaction, …
Freezer Manager
Position Title: Freezer Manager Department: Freezer Supervisor: Assistant Branch Manager/Branch Manager FLSA: Exempt Position Summary: Responsible for receiving product and ensures t…
Telemarketer - State Farm Agent Team Member
Job Description Job Description Position Overview Successful State Farm Agent is seeking a qualified professional to join their winning team for the role of Telemarketer - State Farm Agent Tea…
Paint/Hardware Sales Associate
Position Overview: Role: Paint & Hardware Sales Associate Type: Permanent, part-time/full-time Salary: Hourly, Starting at $17.00/hour Location: Carmel, NY (Putnam County) Reports To:…
Direct Support Professional DSP
Job Description Job Description We are seeking a Direct Support Professional DSP to join our team! You will assist in the daily care of elderly or disabled individuals. Pay Rate - $17.5/hr …
Shift Lead
Our Fast growing company is looking for a Shift Manager to oversee all restaurant operations, including welcoming and serving customers. Shift Manager responsibilities include delegating tasks to res…
RN for PCM Management
Job Description Job Description The RN Principle Care Management (PCM) Program Manager is responsible for overseeing the PCM program, ensuring high-quality, patient-centered care for individuals …
CNC Programmer
Job Description Job Description Description: The CNC Mill Programmer is responsible for the generation and execution of .NC programs utilizing 3-4 Axis Vertical (Horizontal is a plus) CNC cont…