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CSV Consultant

Inteldot

CSV Consultant

Summit, NJ
Full Time
Paid
  • Responsibilities

    Requirements:

    1. Site: BMS, Summit, NJ

    2. Duration: 18 months

    3. Estimated Start Date: June 2020

    4. Remote or Onsite: Onsite

    5. Shift: 1st & 2nd There will be periods of work needed during weekends.

    6. Process or Area Experience (Fill Finish/Packaging/Manufacturing….): CSV and Requalification Personnel

    7. Industry: Pharmaceutical / Biotech

    8. Education: Bachelor's degree in Engineering or Sciences fields

    9. Supervision or Leadership or any specific or required personal trait: 1 Lead for Non-CSV Validation and 1 Lead for CSV

    10. Total resources requested: minimum of 9, the RFP asks for 50

    11. MD/GMP Non-Computerized Systems; Non-GMP Equipment; Unplanned work;

    12. Requalification – 6 resources (1 them as lead)

    13. MD/GMP Computerized Systems – 3 resources (1 of them as lead)

    14. Most of the equipment for the first phase is laboratory equipment, there are method validation tasks, CSV knowledge is important, self-driven and attention to detail.

    Job Description:

    General – all personnel

    Knowledge of cGMP, GXP, GAMP, and good documentation practices.

    Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.

    Strong written and verbal communication skills.

    Excellent interpersonal skills with experience dealing with a diverse workforce.

    Strong multi‐tasking ability in conjunction with proven organizational skills.  Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.

    Ability to effectively manage multiple tasks and activities simultaneously.

    Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems.

    Innate ability to learn new software, such as corporate intranet and enterprise business.

    Experience authoring, owning and executing qualification documentation.

    Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.

    Author deviations in site QMS: Lead, write up, drive to closure.

    Author CAPA plans in site QMS: Own plan, implement actions and drive to closure .

    Author Change Controls in site QMS: Determine scope and impact of changes; assess changes, execute actions and drive to closure.

    Own Validation Maintenance Actions generated through site Equipment

    Performance Review Program to get the equipment back to it's validated state.

    Controlled Temperature Unit and Storage Area Requalification: Execute temperature mapping of units and storage areas.

    Maintain training compliance.

    For New Equipment and/or relocation of equipment:

    1. Coordinate with site engineering and end user group to create project plan, scope and timeline for new install.
    2. Coordinate with site engineering group to ensure the site is ready to receive a new equipment.
    3. Coordinate with equipment vendor if needed to come to site for vendor installed equipment.
    4. Gather necessary equipment data (manuals, spare parts, maintenance plans, etc.)
    5. Create and load asset information including asset ID, job plans, and maintenance schedules.
    6. Provide successful clean turn over to end user team
    7. Draft qualification, execute and close documentation if equipment is GMP (as applicable): URS, Regulatory determination checklists, Vendor software assessment, FRS, FDS, Commissioning, IOPQ, UAT, Traceability Matrix, VSR

    For Decommissioning of Equipment:

    1. Work with site maintenance team to execute any final calibrations or performance verifications
    2. Get system decommissioned in site CMMS system
    3. Work with engineering, user group, and vendors to remove system

    Requalification personnel

    1. Experience using temperature mapping equipment.
    2. Experience performing temperature mappings for temperature chambers and controlled temperature storage areas (rooms).

    Laboratory systems qualification personnel (installs, quals, relocations, decommissioning)

    1. Experience working with laboratory systems in a laboratory environment
    2. Experience in the qualification of laboratory equipment

    Computer Systems Validation Personnel:

    1. Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements.
    2. Must have experience in configuring computerized systems with complex vendor software systems, and windows operating systems.
    3. Must have experience drafting and executing test plans intended to show system compliance with part 11, including items like, user access levels, audit trails, backup, restore, etc.