- Lilly (Indianapolis, IN)
- …failure modes of the process + Knowing the product process, development and validation history + Translating process requirement and education to the Joint Process ... and sterility and Bioburden control (for parenteral product) strategies and validation process (PV/PPQ) and oversight any documentation associated as required. +… more
- Mallinckrodt Pharmaceuticals (Webster Groves, MO)
- …(batch records, methods, labels, etc ) + Facility/Equipment Qualification and validation (process/cleaning) + Stability data review / stability coordination + CAPA ... + Develop and execute validation and compliance strategy for Webster Groves commercial plant...preferred + Certification as a Quality Auditor or Quality Manager helpful Experience: + Minimum 5 years' experience in… more
- ThermoFisher Scientific (Frederick, MD)
- … pharmaceutical and life sciences manufacturing processes, quality and validation requirements, and global regulatory considerations. Working across R&D, IT, OT, ... IT, and OT needs. + Partner with site operations, IT, engineering, and quality/ validation leaders to compose secure, resilient OT, lab, and R&D environments. +… more
- ThermoFisher Scientific (Cincinnati, OH)
- …pharmaceuticals are made with a simplified, end-to-end supply chain for pharmaceutical and biopharmaceutical companies of all sizes. **Position summary** The ... structure to provide direction and management guidance to Capital Engineering, Validation , Utilities, Automation, and Maintenance activities. In addition to leading… more
- Cambrex High Point (Longmont, CO)
- …data and batch production records, Internal/external audits, supplier/subcontractor management, validation , and calibration & maintenance. This role may participate ... and results for accuracy and compliance with other regulatory guidelines. * Under manager supervision, able to comply with GMP, SOPs and basic regulatory guidance. *… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …ongoing technical support and oversight for a portfolio of Active Pharmaceutical Ingredients (APIs), Intermediates and Starting Materials and/or Oral Drug Products, ... technology transfers as needed + Technical oversight and direction for process validation , as needed + Providing technical guidance in the understanding of root… more
- Sokol Materials & Services (Skillman, NJ)
- …AND RESPONSIBILITIES: * Provide QA support to the Devens site and QA Manager by reviewing and approving investigations and corrective actions (CAPAs). * Make ... * Review and approve documents related to Quality, Quality Control, Validation , and Automation. * Review and approve Standard Operating Procedures (SOPs).… more
- United Therapeutics (Silver Spring, MD)
- …are as follows:** Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit ... a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.… more
- Reckitt (Wilson, NC)
- …a talented team of Process Engineers and Process Technologists, the Technical Manager ensures the efficient, safe, and high-quality manufacturing of liquid and oral ... business imperatives forward. Collaboration is key, and the Technical Manager works cross-functionally to uncover opportunities, deliver impactful improvements, and… more
- W. R. Grace (Tyrone, PA)
- …Tyrone location produces a portfolio of products including specialty pharmaceutical , food grade nutraceuticals, performance chemicals, agricultural chemicals, and ... As the Senior Quality Engineer, you will report to the Quality Assurance Manager and be responsible for carrying out Manufacturing Quality Assurance functions within… more