Senior Validation Engineer - Katalyst Healthcares & Life Sciences

• Write technical documents associated with projects.
• Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV) for facility and utility systems.
• Perform (hands on) field execution of commissioning and/or validation documentation.
• Reviewing equipment lists, instrument lists, drawings, specifications, and submittals to ensure quality, accuracy, and completeness.
• Performing field walk downs to ensure installation meets design requirements.
• Identifying deficiencies during installation and commissioning and ensure correction in a timely manner.
• Actively participate in the mentoring, training of junior engineers and development of internal company policies and procedures.

Requirements:

• BS Engineering or related discipline.
• Minimum 8 years C&Q experience in facility and equipment C&Q in the pharmaceutical, medical device and/or biotechnology industry is required.
• Strong utility and facility commissioning, qualification and validation experience.
• Experience with FDA compliance and cGMP is required.
• Must be results oriented with several years of hands-on experience, familiar with industry concepts, practices, and procedures in a cGMP environment.
• Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
• Demonstrated experience managing others as well as fostering a team focused approach. The ideal candidate shall excel in the areas of communication, leadership, client loyalty, initiative, and business integrity.
• Excellent verbal, oral, and technical writing communication skills.
• Proficient in Microsoft Word, Excel, Power Point, Project and able to quickly learn new computer applications.