What are the responsibilities and job description for the Senior Validation Specialist position at Fusion Life Sciences Technologies LLC?
Cleaning Validation Specialist
Greater Philadelphia Area
Location: West Point, PA
Summary
Client is seeking an experienced Validation Specialist/Engineer to join our professional services team at our clients PA location. This team will support our clients continuing validation team in conducting annual requalification activities, including cleaning, sterilization, and Controlled Temperature Unit (CTU) validation. This role requires self-directed professionals capable of performing these essential tasks with general oversight, as our client provides training, equipment, and materials needed to facilitate the validation processes.
Responsibilities
• Independently manage and complete annual requalification activities for client's validation program , including:
o Cleaning validation
o Sterilization validation
o Controlled Temperature Unit (CTU) validation
• Prepare and write comprehensive validation reports following established protocols .
• Coordinate with equipment owners to schedule necessary time and resources to complete validation activities.
• Collaborate with the Clients Validation Department to meet requirement dates and annual workload objectives.
• Manage assigned studies efficiently, contributing to the team's completion of approximately 600 studies annually
• Other duties as assigned
Skills and Qualifications
• Proven experience in validation activities, including cleaning, sterilization, and CTU processes.
• Ability to work independently with minimal supervision while maintaining a high standard of accuracy and compliance with regulatory requirements.
• Excellent communication and coordination skills to effectively liaise with the Client's Validation Department and equipment owners.
• Strong time-management abilities to handle the expected workload and maintain consistency across studies.
• Commitment to safety and quality, adhering to Safety First, Quality Always standards.
• Flexibility and dedication to maintain a long-term position, ideally for the full five-year contract period.
• Performs other duties as assigned by management.
• Ability to provide required legal US work authorization documents. Will consider US domestic travelers and relocation.
Additional
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Continuous Learning –Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
• Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
• Customer Services – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
• Planning and Organizing – Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives.
Works in an organized manner.
• Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others’ views. Gives and welcomes feedback. Puts success of team above own interests.
• Use of Technology – Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
• Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
• Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
• Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form . Deal with problems involving several concrete variables in standardized situations.