Remote: Eastern Time Zone

Must have: ValGenesis Experience

Summary:

• We believe it’s critical to deliver medical solutions now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. 
• You’ll be working within the Manufacturing Science & Technology (MSAT) and Global Engineering group. As a key strategic enabling function for the Manufacturing network, we support the changing product mix, new modalities and investments for our internal manufacturing capabilities and assets that ultimately bring the Company pipeline to commercial production to deliver for patients.

Description: 

• The Digital Validation Solution Expert (ValGenesis)(Validation Master Data Manager and User Support) is a vital member of our Global MSAT & Engineering team (PTT) responsible for maintaining and updating the master data in a centralized paperless validation system and to provide critical user support within the network.  
• This role involves managing templates and ensuring standardization in our validation system, as well as handling data migration tasks, process change requests, and ensuring accurate record-keeping. 
• This position requires a strong understanding of the Qualification and Validation business processes, an innovative and problem solving mindset along with a strong ability to work collaboratively with interfaces to Global and Local MSAT, Engineering, Quality and IT organizations. 

Key Responsibilities:

• Maintain accurate and organized system validation documentation standards, ensuring it complies with regulatory requirements and company policies.
• Collaborate with cross-functional teams, including Quality, Manufacturing, and Engineering, to ensure successful validation systems and qualification activities.
• Investigate and resolve challenging validation issues by applying scientific and engineering principles, and implement corrective actions as needed.
• Collaboration with suppliers to troubleshoot existing issues, test/deploy new features and support new module Master data build. 
• Work closely with validation and qualification SPOCs, SMEs and Site Business Process Managers in order to get the aligned business process translated into the form of Master Data and enable Communications to the sites for system adoption.
• Responsible for implementation (as applicable) of changes to the master data, not only from a Specification perspective but into the ValGenesis Software for implementation.
• Manage templates upload and binding to the Content types at all the sites in addition to template revisions.

Qualifications:

• Familiarity with the Valgenesis Validation Lifecycle Management System is required.
• 3-5 years work experience in the pharmaceutical or biotechnology industry with process development, operations/manufacturing, or related experience. 
• Proficiency in validation methodologies, risk assessments, and related documentation.
• Experience resolving issues with a variety of project documentation, including business and functional requirements, validation test protocols and technical support documentation.
• Excellent interpersonal and collaboration skills: proven track record of building strong and sustainable relationships with internal and external partners/stakeholders.
• Ability to act as a coach for colleagues with less experience, provide guidance, motivates, and influences other colleagues.
• Demonstrated capability to role model and actively develop effective risk taking and decision making to colleagues with less experience and helps develop skills/expertise.
• Proven capability to foresee and solve problems through identification of med/high opportunities and solutions implementation.
• Excellent communication and presentation skills: exhibits professional maturity, confidence and competence.
• Strong executive presence and resonant communications at all levels - experience framing communications to fit the audience.
• Ability to synthesize and summarize complex issues and conclusions so as to expedite agreements and decision-making.
• Attention to detail and commitment to maintaining data accuracy and integrity.
• Exhibits strong accountability behaviors and is able to manage multiple priorities and remain on track with objectives independently within complex environments.
• Self-starter who actively manages commitments and deliverables without direction and exercises wide latitude in how they approach their work. 

The hiring range for this position is $60.00-$72.00 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.