AbbVie Bioresearch Center in Worcester, MA is seeking an Associate Engineer to join the Quality Validation Group for the validation of biologics equipment.

The selected candidate will be responsible for commissioning and qualification activities associated with lifecycle validation projects involving engineering changes to existing equipment and processes, introduction of new manufacturing processes, support of existing manufacturing processes, and continuous improvement of validation processes to enable more agile change control.  The engineer will work in a multi-disciplinary team environment.

Primary Responsibilities:

• Prepare validation test protocols, perform/coordinate validation testing in concert with all stakeholders, and analyze/assemble test results and complete documentation necessary to create finished validation summary reports as required
• Assist in the review of completed test documentation to ensure compliance with test procedures and cGMPs
• Execute assigned projects, jobs and tasks according to schedule prepared by Engineering Project Management
• Provide input on risk assessments and system classifications
• Review new equipment specifications
• Manage continuous improvement projects and drive to completion
• Work with appropriate departments and personnel to resolve validation testing issues
• Advise other departments on SOPs related to validation projects
• Maintain 100% on time training
• Achieve Site, Department and Group performance metrics
• Complete other special projects and assignments as required
• Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs
• Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Education:

• BS Degree in engineering or technical discipline.
• Entry level position, less than two years of experience is typical.

Qualifications:

• An understanding of basic unit operations involving cell culture and protein purification is desired
• Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation and controls is desired
• Familiarity with Clean-In-Place and Steam-In-Place theory and techniques is desired
• Experience with risk-based approach to commissioning and qualification preferred
• Experience with temperature mapping of environmental chambers, autoclave validation is desired
• Familiarity with distributed control systems and process logic controllers is desired
• Familiarity with P&IDs, loop diagrams, etc. is desired
• Hands-on experience with the Kaye Validator is desired
• Familiarity with project management is desired
• Experience with continuous improvement to streamline practices & procedures is desired
• 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 simultaneously
• Must demonstrate strong interpersonal & teamwork skills

Significant Work Activities and Conditions:

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Continuous standing/walking for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Work in a manufacturing environment with:  awkward/forceful/repetitive (arms above shoulder, bent wrists) use of arms
• Work in a clean room environment
• Lift, carry, push or pull weights of more than 20 pounds on a regular basis
• Routine work with chemicals
• Wear ear plugs
• Work at heights, e.g. ladders, scaffolds, catwalks, etc.
• Work requiring repeated bending, stooping, squatting or kneeling