Senior Technical Consultant

7 days ago

Lexington, United States Apolis Full time

Job Title - Technical Consultant

Duration: 12 months assignment (Possible scope to extend depending on performance and/or budget)

Location: Lexington, MA 02421

Description:

Onsite Expectations:

For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting working on projects, it is a minimum 3 days a week onsite, there will be times to be on site 4-5 days as needed.


Job Description:

The QC IT Application Analyst collaborates with the business and IT teams to provide project support for MA Biologics Operations Site Functions – Quality, Validation and Product Development.

The QC IT Application Analyst manages their work with limited oversight-

The scope of work includes, but is not limited to the following:

Project upgrades from win 7- win 10

Provide oversight of vendor-provided solutions

Handle ad-hoc technical requests from both internal and external partners in accordance with projects that are assigned.

Work with other Direct team members for descions, and clariffications as needed

Must be able to juggle multiple projects and deliverables, and split billing time between projects where needed.

Experience with performing design testing of application to help author SDLC documents, including SDCS, URS, FRA, Admin Sop, IQ, IOQ, ATR, Application Data Flow diagrams, etc.

Must poses GXP experience with lab equipment.


Education and Experience Requirements

More than 5 years relevant IT/business experience, analysis, and documentation of business and technical requirements (required)

Experience with software application implementations in GxP environment(required)

Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration,

Experience in the Pharmaceuticals or Life Sciences industry (preferred)

Experience consulting or working in a complex, global matrix organization(preferred)

Knowledge of Lean operational techniques (preferred)


Key Skills, Abilities, and Competencies

IT Technology Skills & Competencies

IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments – Empower, Chromeleon, SOLO VPE, GEUnicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, GEDataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX,PerkinElmer Asset Genius, Thermo WebAdmin for TruScan RM Analyzer, and various Laboratory desktop applications used in GxP environment

Familiarity with Automation systems such as SCADAs, PLCs, DCS, BAS, Historians

Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance

Experience working with ITIL processes in ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)

Familiarity with following tools and processes –

TrackWise – CAPA, Deviation, Change Control

Veeva – Document Workflows

Familiarity with Operational Excellence and/or Continuous Improvement processes

Knowledge and familiarity of following Tools and technologies

MS Office 365, MS Visio, MS Project

Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP,Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore

Architectures – 2 Tier, 3 Tier, On-premise, Cloud

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