Fill Line GAP Assessment/Remedation Consultant - Charleston, SC (REF8017L)
- Main St, Charleston, SC 29407, USA
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.
Client is looking for a fill-line validation subject matter expert for a 4 month (plus likely extension), on-site GAP assessment and remediation project. Duties and responsibilities include:
- Supplemental Engineering Risk Assessments (Process, Utilities, Manufacturing, Environmental, Safety, etc.) to be issued as completed
- Progressive engineering design development of Preliminary design building/facility and multi-discipline systems drawings, schematics, diagrams, specifications, User Requirement Specifications/Datasheets and other supporting engineering documentation
- Material, Equipment, Personnel and Waste Flows outside the building footprint
- Development of a Preliminary Design Project Scope of Work narrative document (multidiscipline)
- Performance of constructability reviews and utility assessments
- Development, coordination and Bid Package release, review and recommendations with and of pre-selected Equipment Vendors for
- Budgetary Equipment Pricing for Long-Lead Critical, including lead times for delivery
- Preliminary Automation Strategy development
- Preliminary CQV Strategy development
- Preliminary Procurement & Subcontracting Strategy development
- Preliminary EPCMV Project Schedule development
- Updated Capital Cost Estimate, including assumptions for owner’s Indirect costs development Preliminary project spend curve to support EBSI’s project funding
- Design Coordination with EBSI/Bergmann, Pre-engineered Building Contractor, and GCON
- Facilitation and coordination of Weekly Design Progress Review Meetings
- Document Control and Administration
- Project Design Progress Management and Reporting (every two weeks), including Earned Value Tracking, Cost and Schedule
- Management and Project Change Order Management
- Joint Progress Design Review Meetings with the EBSI team members will be held weekly during the Preliminary Design Phase. Summary meeting notes for review and record will be distributed. Meetings will be conducted and attended via Teams or similar platform
- Qualified candidates will possess a Bachelor’s degree in related field along with 10 plus years related industry experience.
- 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 does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***