ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
Facility Maintenance: Supports Managers with technical direction for set up and troubleshooting of equipment, systems, and processes. Actively review reports and documents for compliance to requirements and troubleshoots issues. Provides hands-on training on various systems. Ensures that all critical systems operate in a validated state.
Engineer & Validation: Represents engineering and validation for new systems and equipment by providing technical information, writing, and review of URS documents. Directs engineering efforts on new or changing processes, equipment, and systems. Manages engineering and validation efforts for FAT and SAT commissioning activities. Manages and directs the generation and execution of protocols for qualification events. Manages, writes, reviews, and revises procedures to support new systems or new product realization projects. Maintains professional and technical knowledge by attending educational workshops and reviewing professional publications.
Purchasing: Uses the purchasing system to procure equipment, systems, and supplies.
DCR System: Actively uses the DCR System to change or add new document requirements.
CIMP System: Assists Managers and leads projects for continuous improvement and Kaizen events.
NCR System: Supports the nonconformance system through reporting of Nonconformances and supporting Quality in investigation activities. Provides reports and communication based on investigation findings.
Training: Provides training to other employees to support continued competency.
Preparing and executing validation documents.
Project execution for multiple systems validation.
Understanding the hours budgeted for completion of each task on a specific.
Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers.
Develop Installation, Operational and simple Performance qualification documents.
Qualified candidates will possess a Bachelor's degree in related field along with 10 plus years related industry experience.
Project Management, Performance Management, Staffing, Management Proficiency, Coaching, Developing Standards, Process Improvement, Decision Making, Troubleshooting, Quality Management, Project coordination and management, P&ID reading, CAD or similar engineering software, commissioning and qualification principles, ISO Systems.
Candidates must have excellent verbal communication and technical writing skills.
Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
Familiarity with many aspects of validation is expected.
Experience with temperature mapping.
Proficient in Microsoft Word, Excel, Power Point and Project.
Must be willing to travel regionally and/or nationally throughout the US.
All candidates must be legally eligible to work in the United States.
We are an equal opportunity employer. M/F/D/V
Propharma Group, Inc.