Validation Engineers III

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Validation Engineers III

Employer:

EMD Millipore Corporation
400 Summit Drive, Burlington, Massachusetts 01803
Job Site: 11 Prescott Road, Jaffrey, New Hampshire 03452
Travel: 10% domestic travel and 5% international travel required

• Design and lead intermediate to complex level equipment and process validation activities;
• Lead investigations on validation protocol discrepancies to identify the root causes;
• Lead change requests in Change Management system, ensuring implementation solutions support operational needs and meet quality standards;
• Execute Quality System elements like CAPAs, Change Controls, Deviations and Investigations resulting from equipment, utilities, and raw materials qualification;
• Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and raw materials;
• Perform Validation program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in validated state;
• Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design meets manufacturer's specification and functional requirements;
• Prepare, maintain, and review Validation documentation for DQ, FAT, IQ, QQ, PQ, and process qualification;
• Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment; and
• Consult with management, assessing customer requirements to select validation objectives and standards.

Employer requires a Master’s degree in Engineering, Biology, Chemistry, Computer Science, or a closely related field and three (3) years of progressively more responsible work experience as a Validation Engineer or related occupation in the pharmaceutical or medical device industry. In addition, the employer requires the following:

• Demonstrated knowledge of computer system validation life cycles through LIMS, PLC, and HMIs equipment and systems gained through one (1) year of work experience;
• Demonstrated ability in releasing clean rooms for GMP production use complying to FDA regulations in the Biotechnology industry gained through two (2) years of work experience;
• Demonstrated knowledge of product qualification and equipment validation in the pharmaceutical, Bio Tech, life sciences industries gained through two (2) years of work experience;
• Demonstrated ability collaborating with individuals at all levels and functions of the organization and with external customers on critical projects gained through three (3) years of work experience; and
• Demonstrated knowledge of data analysis methods, software, and tools, such as Minitab gained through one (1) year of work experience.

Alternatively, The Employer Will Accept a Bachelor’s Degree In Engineering, Biology, Chemistry, Computer Science, Or a Closely Related Field And Five (5) Years Of Progressively More Responsible Work Experience As a Validation Engineer Or Related Occupation In The Pharmaceutical Or Medical Device Industry. In Addition, The Employer Requires The Following:

• Demonstrated knowledge of computer system validation life cycles through LIMS, PLC, and HMIs equipment and systems gained through one (1) year of work experience;
• Demonstrated ability in releasing clean rooms for GMP production use complying to FDA regulations in the Biotechnology industry gained through two (2) years of work experience;
• Demonstrated knowledge of product qualification and equipment validation in the pharmaceutical, Bio Tech, life sciences industries gained through two (2) years of work experience;
• Demonstrated ability collaborating with…