- Adecco US, Inc. (Chelmsford, MA)
- …safety awareness * Adhere to policies, work instructions, quality regulations, SOP's, WI, cGMP 's, GDP's and FDA guidelines in the effort to manufacture high quality ... medical devices at all times * Utilize microscopes and magnifiers to complete work instructions * Utilize a variety of hand tools and machinery to complete assigned manufacturing activity * Perform in-process quality inspections to standards * Accurately… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …filtration, and potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements (FDA, EMA, ICH). ... + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). + Excellent communication, collaboration, and influencing skills. + Ability to work… more
- Insight Global (Norwood, MA)
- …and problem-solving skills. (Electrical & Mechanical) * Proficiency in maintaining cGMP records (paper and electronic). * Excellent communication and interpersonal ... skills. * Physical stamina for manual labor. * In-depth knowledge of RODI, pH neutralization, HVAC, electrical, plumbing, and mechanical systems. * HVAC/AHU expertise: air handling, lab exhaust, valves, coils, sensors, and VFD diagnostics. * Strong mechanical… more
- Bristol Myers Squibb (Devens, MA)
- …Science or Chem/Bio Engineering + Minimum 0-3 years of industry experience. cGMP and/or Cell Therapy manufacturing experience preferred. This job description is ... intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job… 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 an Automation Engineer II. The Automation Engineer II is expected to assist senior engineering staff in the design and implementation of automation systems for clinical and commercial manufacturing. The candidate provides support in automation… more
- Bristol Myers Squibb (Devens, MA)
- …such as Python, R, etc., is a plus. + Expert understanding of cGMP regulations and/or business and documentation processes. + Highly proficient in technical writing ... and technical presentations, contributing to broader external and internal scientific community as appropriate. + Ability to work in a self-driven, performance/results oriented, fast paced matrix environment. Excellent communication, writing, sense of urgency,… more
- ThermoFisher Scientific (Plainville, MA)
- …**Responsibilities** + Complete work instructions while aligning with procedures and cGMP regulations. + Maintain and update batch records and data sheets ... accurately. + Operate and monitor equipment and automated systems. + Maintain inventory records of raw materials used in production. + Inspect finished products to ensure they meet specifications. + Support timely closure of Nonconformance's/ CAPAs. + Identify… 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
- Bristol Myers Squibb (Devens, MA)
- …tools. + Lead planning and communications for cutovers to ensure regulatory and cGMP compliance. + Conduct lessons learned with project teams and share with ... organization to foster continuous improvement. + Coach organization on project and portfolio management process. + Ensure that team recommendations related to project direction, timelines, and budget, which need endorsement by governance teams, are planned for… more
- AbbVie (Worcester, MA)
- …with continuous improvement to streamline practices & procedures is preferred + Adherence to cGMP and GDP is required + Strong technical writing skill is required + ... Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are preferred + Must be able to work independently with adequate supervision, multi-task and support several projects… more