Easter Seals Jobs

Description:

Joining a collaborative team providing Commissioning, Qualification, and Validation (CQV) support to manufacture GMP products. • Executing CQV protocols using Good Documentation Practices (GDP), investigating and resolving protocols exceptions or anomalies, developing technical reports, and CQV summary reports. • Developing Scientific and Engineering studies to support product and process development for technology transfer, executing Designs of Experiment (DOE), and developing process ranges. • Create and Revise Lifecycle document (i.e., Design Specifications Documents, Functional Specification Document, Software Specifications Document, etc.) • Reading and verifying facility and equipment drawing (e.g., P&IDs, PFDs, etc.). • Generate and execute Installation and Operational Qualification of new hardware, equipment, instrument, and software. • Developing Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documents

Skills:

equipment validation, protocol writing, GMP, validation, Commissioning, pharmaceutical packaging, minitab, capa, change control, URS, DOE

Top Skills Details:

equipment validation,protocol writing,GMP,validation

Additional Skills & Qualifications:

• Experience in a GMP Manufacturing environment (minimum 3 years). • CQV experience in the Life Sciences industry (minimum 4 years). • Experience in creating and executing CQV protocols (minimum 5 years). • Experience in creating and executing Scientific or Engineering Studies (minimum 2 years). • Proficient with Microsoft Office - Word, Excel, PowerPoint, Project. • Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations. • Knowledgeable of Quality Management Systems, such as Change Control, CAPA, and Deviation. • Knowledgeable of Validation and Commissioning/ Qualification Requirements. • Knowledgeable of Technology Transfer, Process Development activities, and Designs of Experiment (DOE

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.