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POSITION SUMMARY:

The Validation Engineer III serves as the subject matter expert for the validation of equipment and systems in accordance with cGMP regulations.  Maintains all documentation pertaining to qualification and validation.  Develops and approves procedures and/or protocols.  Also serves as information resource for validation technicians, contractors and vendors.  Provides timely guidance and assistance, as required, to other validation technicians in order to meet the validation schedule and resolve/close discrepancies and CAPAs.                                         

ESSENTIAL FUNCTIONS:

•  Leads major validation projects, as required, on behalf of the validation department to schedule validation work, timelines, re-qualifications, or any other validation scope of work.
• Assists with the prioritizing the review and approval of validation protocols/summary report prepared by other validation technicians
• Identifies and implements timely lean opportunities within the department and site
• Generates, updates and reviews validation protocols and reports including installation, operation, and performance qualifications, test studies, and standard operating procedures for facility and process equipment.
• Collaborates with Team to develop and maintain Validation databases
• Recommends, develops, and implements departmental operating policies, systems, and procedures
• Prepares Standard Operating Procedures, Change Controls, and Incident/Deviation Reports when required
• Keeps abreast of current trends and developments in the field
• Implements action plan for unanticipated events/ projects.
• Assess current state of validation equipment and gathers cost estimates from applicable vendors to replace or upgrade validation equipment in a timely manner, as required.
• Maintains effective working relationship with team associates, department heads, administrators, and general staff.
• Prepares equipment for use in validation studies.
• Performs and schedules validation procedures, and updates the master validation schedule accordingly
• Performs annual SOP review, updating or archiving SOPs and In-Process forms as required.
• Maintains stock of validation equipment, and ensure instruments are in current calibration.
• Troubleshoots problems with equipment being validated and performs repairs when possible.
• Documents all work in accordance with MassBiologics’ protocols and cGMP regulations.
• Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

• Requires a bachelor’s degree in Engineering with 5-8 years of relevant experience
• Effective and proven organization & project management skills
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action
• Knowledge of cGMP pharmaceutical processes and facilities equipment
• General knowledge of cGMP pharmaceutical equipment, instrumentation and lean concepts
• Ability to apply statistical analysis to equipment / system data output is required
• Prior experience in a cGMP regulated environment is required. Working knowledge of current Good Manufacturing Practices (cGMP) and familiarity with the Code of Federal Regulations (CFR) as applicable to biologic manufacturing
• Capable of complex troubleshooting
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Strong critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
• Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills
• Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others
• Demonstrated ability to train others
• Ability to work effectively both independently and as a member of a team