Horizontal Talent Hiring for Software Implementation Specialist Job at Fremont, CA Full Time

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• 5-10 Years implementation, configuring MES systems
• Experienced with clinical manufacturing software’s

Title 21-ONSITE PHX, AZ
Software Implementation Specialist
Direct Hire

Required Experience

• Candidates must possess 5-10 years’ relevant work experience using, implementing, configuring and validating an MES or similar system in a CGT 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 cGMP, Research/Clinical/Laboratory setting
o BMT Stem Cell Labs, BMT Clinical Case Management
o Immunotherapy or Regenerative Medicine Cell processing and manufacturing
o Other biologic processing/manufacturing technologies

Responsibilities

• Deliver complete customer delight!
• 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.

Title21 Health Solutions | 2325 E. Camelback Rd., Suite 320, Phoenix AZ 85016 | 1-866-TITLE21 | Title21.com | [email protected]

• 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.

Minimum Required Skill Set

• Strong technical skills and familiarity with software technology
• Demonstrated ability to learn quickly and add value immediately in a fast-paced environment.
• Demonstrated ability to work as both a team member and as an individual contributor.
• Excellent time management skills.
• 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.

Desirable Experience

• Experience working within, or implementing relevant regulations and standards as mentioned above.
• Experience in training customers on Clinical Software Applications.
• Hands-on experience troubleshooting and analyzing system issues.

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.
• Ability to be agile in a high growth, fast-paced environment.
• Willingness to learn, grow and take on more responsibilities.
• Desire to learn and master the Title21 software systems.
• Self-starter, reliable, conscientious, customer-focused team member.

Title21 Health Solutions | 2325 E. Camelback Rd., Suite 320, Phoenix AZ 85016 | 1-866-TITLE21 | Title21.com | [email protected]
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