Job Title

Requisition

Location

Additional Locations

Job Description

Summary of Position

Implements and executes validation projects including Equipment Validation, Packaging Validation, Computer System Validation, Data Integrity Assessments, and Cleaning Validation. Coordinates with cross-functional resources in the execution of validation projects and ensure compliance with FDA, cGMP, and any other appropriate regulations. Supports manufacturing and packaging with new product introductions, process improvements, review and approval of change control documentation, review of triages/exceptions related to deviation of manufacturing process and provides technical support as required. Ensures product quality through robust testing and process monitoring including use of statistical process control techniques, Six Sigma tools, understanding of current compliance and technology trends, and application of related pharmaceutical experience.

Equipment & Processes Maintained in a Validated State

Assists with multiple cross-functional projects from development through release to production. Projects include new facilities startup, manufacturing equipment and packaging line FAT and qualifications. Independently executes activities in support of the Validation Department priorities with minimal guidance from the department manager. Provides technical assistance during investigations of process/product issues. Supports validation deviations of process/product or equipment. Execute validations as needed, including assisting in product sampling, auditing and technical review functions as defined in study protocols. Analyzes data, utilizing appropriate statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.

Reviews and approves change control documentation to assure all validation requirements are detailed in the action items.

Protocols & Reports Meet Organizational Requirements

Develops protocols using engineering experience and statistical process controls.

Prepares and maintains validation records in accordance with department procedures to ensure compliance with current standards.

Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures alignment with corporate procedures.

Current with Industry Trends through Continuous Improvement

Stays current with regulatory requirements and creates remediation plans.

Drives continuous improvement to stay aligned with industry trends.

Works cross-functionally with team, other departments, and corporate validation to support improvements.

Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Willing to challenge current practices.

Experienced with using tools like FMEA to use a risk-based approach to determine and prioritize actions.

Education:

Bachelor's degree in engineering discipline or technical field related to pharmaceutical manufacturing is preferred or associate degree with equivalent combination of education, experience, and competencies may be considered.

Experience:

Minimum of 5-10 years of previous validation experience in pharmaceutical manufacturing, with an emphasis on equipment qualification, computer system validation, data integrity, cleaning validation and packaging validation.

Preferred Skills/Competencies:

• Experience with data integrity assessments and remediation as well as computer system validation. (Required)
• Strong technical and mathematical aptitude.
• Training or certifications in regulatory and cGMP requirements is desired.
• Familiar with FDA, USP, and ICH regulations and guidance.

Other Skills/Competencies:

• Strong computer literacy-MS office products, statistical analysis (Minitab) and database usage. Knowledge of statistical process controls is also required for equipment qualifications. Strong communication skills.

• Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she see as challenging; not fearful of action with minimized planning; seizes more opportunities than others.
• Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies.
• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
• Organizing: Can marshal resources (people, finding, material support) to get things done; can orchestrate multiple activities at once to accomplish a goal; uses resources effectively and efficiently; arranges information and files in a useful manner.
• Project Management: Manages projects according to a standard process by using a systems development lifecycle; effectively directs and integrates all aspects of a project or program, ensuring that work progresses toward achieving goals and objectives; achieves expected results through the successful and timely completion of activities; at the end of a project, with project team, takes time to determine what was learned that can be applied to future projects.
• Written Communications: Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.
• Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.

Physical Demands/Work Environment

Physical/Visual Activities or Demands: Physical/visual activities or demands that are commonly associated with the performance of the functions of this job:

• Exert a negligible amount of force continuously and up to 20 pounds of force occasionally to lift, carry, push, pull or move objects. Involves sitting, walking, and standing, reaching, talking and hearing.
• The job involves clarity of vision at 20 inches or less with ability to bring objects into sharp focus. May need the ability to identify and distinguish colors.
• Flow of work and character of duties involve normal mental and visual attention much or all of the time.

Environmental/Atmospheric Conditions commonly associated with the performance of the functions of this job:

• Usual office working conditions. Work performed in or have exposure to lab and pharmaceutical processing environments.
• Ability to be fully gowned including use of respirator to be present during product processing.

Compensation range: $80,000.00 - $110,000.00