The Validation Engineer I will support the Qualification / Validation / Calibration / Preventative Maintenance programs from the introduction of new equipment or processes to requalification / revalidation/recalibration to decommissioning and review of preventative maintenance.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Responsible for Developing Equipment Commissioning, IQ/OQ/PQ and DQ protocols and execution, utility systems, facilities, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
- Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
- Complies validation data, for management review, prepares reports and makes recommendations for changes and/or improvements.
- Assist with investigation and troubleshoot problems which occur and help determine solutions.
- Coordinates and executes validation change control and preparation of draft protocols, report, and data tables.
- Ability to multi-task and methodically manage projects
- Maintains all documentation pertaining to validation.
- May assist in developing procedures and/or protocols.
- Coordinate and assist contract personnel through completion of assignments
- Works on cross-functional project teams as required.
- May provide day-to-day guidance and training to other validation technicians.
- Serves as an information resource to validation technicians, contractors, and vendors.
- Resolves validation issues of moderate scope with limited direct supervision.
- Other department validation tasks as assigned.
- Bachelor’s degree (preferably in an engineering discipline or related science field)
- 3 - 5 years in a cGMP-related industry with at least 2-4 years of manufacturing/validation experience working with cGMP pharmaceutical/nutraceutical regulated industries preferred.
- Knowledge of cGMP practices, aseptic techniques, and FDA Regulations.
- Experience developing and executing process, equipment, and cleaning validation protocols a plus.
- Excellent written and verbal communication and interpersonal skills; prefer an individual with a positive, results oriented, team mindset and capable of changing direction and focus as priorities shift.
- Capable of demonstrating strategic thinking by maintaining a focus on project goals and global targets while meeting near term objectives to secure their implementation.
- Ability to establish clear priorities quickly
- Ability to work effectively under pressure, handle multiple project, and meet deadlines
- Strong verbal and written communication skills, good decision-making skills, and time management skills are a must; ability to interface with all levels of the organizations.
- Ability to write technical documents (IQ/OQ/PQ/DQ protocols and reports etc.)
- PC literate, Microsoft Office and spreadsheet software
- Mathematical reasoning and ability
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Ability to work flexible hours and inconsistent schedules as necessary to meet business demands and established timelines
While performing the duties of this Job, the employee is regularly required to stand and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must and occasionally lift and/or move up to 25 pounds.
Work environment will vary to include:
office atmosphere, clean room aseptic manufacturing areas, mechanical utility spaces, walk in cold rooms, warehouse. Environmental conditions will be moderate temperature fluctuations, moderate humidity, moderate noise levels, close proximity to hazardous utilities, fumes, or chemicals is possible. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts; toxic or caustic chemicals. The noise level in the work environment is usually moderate.