- Bristol Myers Squibb (Devens, MA)
- …and completely understand, follow, interpret and apply global regulatory and cGMP requirements. + Demonstrated advanced technical writing skills. + Advanced ... strategic thinking and problem-solving ability/mentality, technically adept and logical. + Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects. + Advanced ability to communicate and… more
- ThermoFisher Scientific (Boston, MA)
- …Values + Experience in laboratory setting or services preferred; experience in cGMP environment preferred + Excellence in customer service skills + Detail oriented, ... problem solver, promotes team environment + Exhibit a strong passion for customer satisfaction, and the interpersonal capabilities to communicate effectively with personnel across different levels at the customer site + Must deliver excellent customer service… more
- Turner & Townsend (Boston, MA)
- …**Market sector experience:** + Pharmaceutical manufacturing and R&D facilities + CGMP facilities **Project/program size in dollar value:** + Various, with projects ... ranging in size from $50m to $1bn **Software specific requirements:** + CostX experience preferred but not essential. Experience in measurement software essential. **Certification requirements:** + AACE membership or equivalent preferred but not essential.… more
- C&W Services (Braintree, MA)
- …viable excursion contamination. This role requires strict compliance with cGMP standards, established cleaning protocols, and company Standard Operating Procedures ... (SOPs). As a union position, the GMP Cleaner may be assigned to specific locations and must be flexible with scheduling, including non-standard shifts, weekends, holidays, and overtime as required. This position is critical to ensuring a sterile environment… more
- Bristol Myers Squibb (Devens, MA)
- …facility, in accordance with BMS policies, standards, procedures and Global cGMP . They will oversee atypical events to ensure the appropriate management ... notifications occur per procedure. This individual will coordinate with stakeholders to gather supporting documentation and content for the Material Review Boards to facilitate options for delivering Drug Product to patients. The primary stakeholders for this… more
- Astellas Pharma (Westborough, MA)
- …equipment, cleaning validation and process performance qualification for AIRM/ MA-TC's cGMP Cell Therapy Manufacturing facility in Westborough, MA as products move ... through clinical trials and commercialization. The Validation Lead will be a leader and SME accountable for validation strategy, and managing validation projects. The candidate will be responsible for oversight of qualification and validation procedures and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …for the performance, organization and oversight of maintenance of the CMCF cGMP cleanroom spaces, equipment and supporting utilities. This position has several key ... roles and will interface with key cross-functional groups across the Dana-Farber Cancer Institute. The position is focused on providing hands-on expertise to ensure all cleanroom suites are functioning as intended. Located in Boston and the surrounding… more
- Catalent Pharma Solutions (Chelsea, MA)
- …dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions is ... hiring a Facility Maintenance Engineer. The Facilities Engineer is responsible for the maintenance activities (preventive and corrective) and troubleshooting of Heating, Ventilation, Air Conditioning (HVAC) systems, Good Manufacturing Practices (GMP)… more
- Catalent Pharma Solutions (Chelsea, MA)
- …dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions is ... hiring a Quality Assurance (QA) Specialist II. The Quality Assurance Specialist II is responsible for supporting daily operations in a GMP (Good Manufacturing Practices) Manufacturing Facility. This individual provides oversight of production activities with… more
- ThermoFisher Scientific (Bedford, MA)
- …in a team, share data, and collaborate to resolve issues. + Familiarity with cGMP and ISO 13485 requirements, including CAPA and Risk Assessments. + Experience with ... Lean/Process Excellence/Six Sigma methodologies. + Strong project management skills. + Understanding of process validation. **Additional Proficiencies:** + Adaptability to a dynamic environment while maintaining a focus on quality. + Good understanding of… more