Senior Software Implementation Specialist

Title21 Health Solutions, a leading provider of Health and Life Science data management solutions, is seeking a Software Implementation Specialist II at its Phoenix, AZ location. The Software Implementation Specialist is responsible for providing business domain and technological expertise in support of the configuration and deployment of Manufacturing Execution Systems (MES) into the life science domains. These include Cell and Gene Therapeutics (CGT), immunotherapy, and regenerative medicine spaces in the context of biologic-drug development, including IND and commercial cGMP manufacturing, CDMO/CMO and CROs.

Software Implementation Specialist Candidate Background

This position seeks an experienced professional with deep understanding of cGMP Biologic-drug development and manufacturing processes, regulatory and quality for CGT and related fields.

Required Experience

Candidates must possess 5-10 years' relevant work experience developing, implementing, configuring and validating an MES or similar system in a CGT manufacturing or related domain

Experience as a super user of commercial or clinical manufacturing software applications

Working knowledge, familiarity and experience with pertinent standards and regulations including CMC, GAMP5, FACT, FDA (21CFR Part 11, Part 1271, etc.), ISO, and Public Health Services Act (Section 361) Regulations.

Demonstrated domain expertise in one or more of the following areas

o Cellular and/or Gene Therapy Manufacturing in the commercial cGMP domains

o Immunotherapy or Regenerative Medicine Cell processing and manufacturing

o Other biologic processing/manufacturing technologies

Responsibilities

• Gain and demonstrate mastery of the Title21 Health Solutions system, including performing business and requirements analysis, workshop facilitation, system configuration and implementation, user acceptance testing, validation, and post go-live support activities.
• Gain and demonstrate deep understanding and familiarity with the target customer domain(s) including, commercial manufacturing, clinical, laboratory workflows, compliance and regulations, Quality Management, Inventory/ Supplies Management, Training/Learning Management and Content Management.
• Perform analysis of customer's business requirements/workflows/processes/expectations and translate and configure into Title21 Health Solutions product. Identify gaps early in deployment cycle.
• Assist customer's project team in understanding the Title21 system capabilities, and steering the team to ideal solutions that map their requirements into the software.
• Troubleshooting and resolving customer issues. Provide consultative telephone and email support.
• Configure, deploy, validate and review validations of the software solution to meet customer requirements.
• Communicate and present in a simple and effective manner the capabilities and functionality of Title21 Health Solutions as it is relevant to the customer's domain and objectives.
• Lead meetings (both face-to-face and remote) as part of the gathering and development of requirements.
• Develop and managing all aspects of the requirements documentation at all levels of the deployment process (Customer Requirements (PRD), Data Dictionaries, Workflow Requirements, Test Requirements, Traceability Matrices, Interface specifications, etc.)
• Support sales team with demonstrations and technical/industry expertise throughout the sales process. Help translate the key customer benefits to the market (Webinars, sales calls, etc.)
• Conducting all levels of training at customer site and Title21 locations.
• Deliver assignments on time and of high quality.
• Feedback customer issues and work with the development group to resolve customer needs.
• Participate in user groups with webinars, conference calls, tech talks, etc.

Requirements

Minimum Required Skill Set

• Strong technical skills and familiarity with software technology
• Excellent verbal, public speaking, and written communication skills. Ability to effectively document results.
• Demonstrated ability to deliver clear, concise instructions, communicates difficult concepts simply and effectively, and maintains professional presentation skills.
• Highly detailed oriented with extremely good follow-up.
• Excellent interpersonal skills with a genuine enthusiasm in the aforementioned fields.
• Strong familiarity with Windows/PCs environments.
• Strong initiative and ability to thrive in self-directed work teams.
• Strong critical thinker with the ability to learn new systems, synthesize information and formulate recommendations.

Personal Traits

• Ability to work independently and self-starting.
• Enjoy working on a team with enthusiastic, talented professionals; being a team player and enjoying a collaborative environment is essential.
• Desire to learn and master the Title21 software systems.

Educational Requirements

• Minimum BA/BS 4-year degree in a relevant Health or Life Sciences. Advanced degree is highly desirable.

Position Type

• Full-Time Employment; Non-Exempt. Sponsorships considered for highly qualified candidates.

Travel

• Required; approximately 20%

Location

This position is located in Phoenix, AZ.

Benefits

Title21 Health Solutions provides a competitive compensation and benefits package including:

• Medical Plan, Dental/Vision plan
• 401(k) with company match
• Paid Holiday/Vacation/Birthday/Personal days
• Life/Disability Insurance Plan