Requirements:
Site: BMS, Summit, NJ
Duration: 18 months
Estimated Start Date: June 2020
Remote or Onsite: Onsite
Shift: 1st & 2nd There will be periods of work needed during weekends.
Process or Area Experience (Fill Finish/Packaging/Manufacturing….): CSV and Requalification Personnel
Industry: Pharmaceutical / Biotech
Education: Bachelor's degree in Engineering or Sciences fields
Supervision or Leadership or any specific or required personal trait: 1 Lead for Non-CSV Validation and 1 Lead for CSV
Total resources requested: minimum of 9, the RFP asks for 50
MD/GMP Non-Computerized Systems; Non-GMP Equipment; Unplanned work;
Requalification – 6 resources (1 them as lead)
MD/GMP Computerized Systems – 3 resources (1 of them as lead)
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:
For Decommissioning of Equipment:
Requalification personnel
Laboratory systems qualification personnel (installs, quals, relocations, decommissioning)
Computer Systems Validation Personnel: