1.0 Summary

Validation Specialist II is a full-time specialty, technical, professional position. A Validation Specialist II is responsible for reviewing engineering design documentation, developing testing methodologies, authoring commissioning, qualification, and validation testing protocols, performing (executing) field testing, and authoring final reports to completed testing. An Analytical Instrument Validation Specialist is responsible for understanding the design and operation of laboratory/analytical instrumentation, software validation, data analysis, system configuration/ privileges for data integrity (where applicable), and integration into standard operations instructions and preventive maintenance plans.

2.0 Position Basic Qualifications:

2.1 Appropriate Education:

2.1.1 Bachelor of Science degree (or equivalent conferred degree) in Chemistry, Biochemistry, Microbiology, Chemical engineering, Biotechnology/Pharmaceutical Engineering, or equivalent program and 5 to 10 years of experience in performing qualification of laboratory test instruments, methods or performing operational tests, preferably in pharmaceutical, biotechnology, or related engineering industry/field; or

2.1.2 Master of Science degree (or equivalent conferred degree) in Chemistry, Biochemistry, Microbiology, Chemical engineering, Biotechnology/Pharmaceutical Engineering, or equivalent program and 1 to 5 years of experience in above system testing.

2.2 Authorization / eligibility to work in the United States.

3.0 Position Requirements

3.1 Able to author impact assessments, user requirements, functional specifications, system design requirements, validation plans, qualification protocols (i.e. IQ, OQ, PQ) traceability matrices, reports, addendums, decommissioning plans and other validation deliverables required by the site validation SOPs.

3.2 Ensure lab instrument’s adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, CFRs and global health authority regulations and guidances, Pharmacopeia, ICH, CLIA/CAP, and NYS CLEP.

3.3 Able to review vendor qualification documentation and develop protocols to fully complete user requirements.

3.4 Able to troubleshoot issues and formulate strategies with end users to mitigate gaps (i.e.by additional testing, instructions).

3.5 Experience with analytical instrument software and data transfer logistics (e.g., Empower, OpenLab, PI, SQL, etc.) a plus.

3.6 Able to author, execute test plans, and review executions/ data per validation principles and good documentation practices.

3.7 Able to lead and train other engineers in document development, data review, and executions.

3.8 As Subject Matter Expert, lead technical discussions, troubleshoot issues, propose solutions, and gain resolution from stakeholders (i.e. end user, lab owner, quality assurance, validation).

4.0 Operational Responsibilities

4.1 Supports identification of new opportunities at assigned project /client site(s)

4.2 Supports development of scope documents, estimates, and proposals for prospective projects.

4.3 Participates in industry associations functions or events.

4.4 Supports specific activities as assigned for development of company infrastructure.

4.5 Supports Marketing and Business Development activities as required.

4.6 Participates in 360 review and employee development processes for continuous improvement.

5.0 Project Responsibilities

5.1 Validation Specialist II reports into the Project Manger or assigned supervisor, is designated SME or point of contact for specific systems and leads/ mentors junior team members.

5.2 Responsible for functioning and operating in a regulated pharmaceutical / biotechnology manufacturing environment, subject to compliance with current Good Manufacturing Practices (cGMPs) and other national or international regulatory requirements as applicable per client site.

5.3 Responsible for preparing, executing, and/or reviewing commissioning, qualification, and validation deliverables as assigned by the Project Manager, or assigned supervisor. Such items may include (but are not limited to) the following: user requirements specifications, user functional requirement specifications, impact assessments, risk assessments, start-up/shake-down plans and procedures, commissioning protocols and test plans, qualification protocols (e.g., IQ, OQ, PQ), final report packages, traceability matrices, standard operating procedures, and decommissioning protocols. May also assist in the development and review of other documentation deliverables required for completion of a project.

5.4 Responsible for providing technical support and technical expertise to project team to facilitate resolution of system and quality issues, either from direct experience or from available source materials.

5.5 Responsible for performing trial runs, commissioning testing (e.g., factory acceptance testing, site acceptance testing, startup/shakedown testing) as identified and assigned by the Project Manager or assigned supervisor. The work may include the preparation or review of the testing protocols.

5.6 Responsible for review of the vendor or contractor documentation as required by the Project Manager or assigned supervisor.

5.7 Interacts directly with client or vendors on an as needed basis regarding system/test method specific activities and basic project related activities.

5.8 Plans, organizes, and tracks assigned tasks to ensure that the schedule commitments are kept.

5.9 Responsible for submitting any required report on progress of assigned tasks (weekly).

6.0 Other Proficiencies

6.1 Proficient in commissioning, qualification, and validation of several system types: liquid handler systems, cell culture analyzers, thermal cyclers, real-time PCR, DNA sequencers, UV/Vis spectroscopy, plate readers, tapestations, controlled temperature storage units.

6.2 Expected software proficiencies: Microsoft Office applications (Outlook, Word, Excel, PowerPoint). Working knowledge and understanding of online collaboration tools (e.g., MS Teams, MS SharePoint, OneNote), project management software (e.g., MS Project, Primavera, etc.), and database software (e.g. MS Access, SAP) is a plus.

6.3 Experience in using Valgenesis for electronic executions is a plus.

6.4 Work is accomplished without considerable direction.

6.5 Works on assignments of diverse and complex scope.

6.6 Interprets less defined guidelines to make recommendations for process improvements and/or enhancements.

6.7 Involves interpreting and analyzing established concepts and trends.

6.8 Exercises considerable judgment for decision-making with complex issues.

6.9 Requires in-depth analysis to identify and recommend new solutions, which require creativity and innovation, for more complex problems.

6.10 Demonstrates thoughtful interactions with a diverse group of individuals, sensitivity to cultural differences in values, beliefs, etc