• Implement and maintain programs ensuring timely and accurate systems validation.
• Collaborate with QA to ensure impeccable GMP systems and equipment validation.
• Ensure compliance with ISO, FDA, and EU requirements through review of available resources and collaboration with Quality Assurance / Regulatory Affairs.
• Mentor subordinates and co-workers, ensure compliance and quality expectations.
• Develop validation master plans/project plans (VMP), revalidation plans and standard operating procedures (SOP) as necessary.
• Work with cross functional teams during the entire process life cycle and provide technical assistance and training as a subject matter expert.
• Coordinate validation activities with site support groups (Operations, Maintenance, Quality, etc.) for timely protocol executions
• Author, coordinate, and execute validation studies (IQ, OQ, PQ, FAT etc.): writing protocols, analyzing, and documenting results, and generate final summary reports. Validation activities include, but not limited to, equipment/system qualification, packaging process validation, cleaning/ sanitization validation, and computer related systems validation
• Act as the site point of contact for all audits regarding calibrations and validations

• Able to lift up to 40lbs routinely throughout the course of a work day.
• Must be able to wear personal protective equipment (latex or nitrile gloves, face shield/safety glasses, hairnets, shoe coverings, etc.)
• Must be able to adhere to applicable biosafety practices when on the manufacturing floor or in laboratories.
• Ability to stand for long periods of time, stoop, reach, push and pull equipment throughout the course of the work shift.
• Ability to work on PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
• May be required to sit for long periods of time though the course of the work shift.
• Must be able to analyze and interpret data.
• Must be able to concentrate and problem solve routinely throughout the course of the work shift.
• Must be able to differentiate colors in product

• Must have the ability to work with multiple departments and employees ranging from individual contributors to high level executives.

• Reports to Director, Quality Assurance & Regulatory Affairs
• Direct Reports

Education and Experience

• Bachelor of Science or Associate of Science and 10+ years’ experience conducting validation or calibration of laboratory instruments in a regulated environment, or
• High School Diploma with 15+ years of industry experience with validations or calibrations of laboratory instruments in a regulated environment.

Competencies Required or preferred

• Strong experience in the development and execution of validation activities.
• Demonstrated ability to evaluate new technologies, new applications of existing technologies and apply information and data from multiple scientific fields of study to create new solutions.
• Effective written and oral communications skills (within all levels of the organization and with external colleagues and collaborators), interpersonal skills, analytical/problem solving skills, cross-functional team leadership skills, and goal setting/time management skills.
• Experience with ensuring protocols, records, and compliance with 21 CFR 11 & 820 cGMP, and ISO.
• Computer knowledge of GAMP, 21 CFR Part 11 and other applicable computer system validation guidance or regulations.
• Ability to validate computer systems including the following features: electronic records, electronic signatures, audit trail, access security, back up/disaster recovery, data acquisition and reports etc.
• Proven and demonstrated computer (PC) and software skills including MS Office Suite programs.
• Possess managerial courage.
• Takes initiative
• Remains calm under pressure.
• Validation lead experience.
• Biotechnology / pharma experience.
• Experience working with diverse laboratory instruments.
• Familiarity with purified water systems, fermenters, and sterilization equipment is a plus.
• Working knowledge of cGMPs and Good Documentation Practices.
• Experience with data collection and reporting.
• Good Communication and Technical Writing skills.
• Proficient with MS Word and Excel (MS Project familiarity is preferable).
• Proficient with Master Control, Blue Mountain Regulatory Asset Manager.
• Familiarity with laboratory safety principles (BSL-2).