Validation Field Specialist - Horsham, United States - Planet Pharma

Description

MUST BE OPEN TO 90% TRAVEL

What You Will Do:

• Assisting in providing information to sales staff regarding site specific equipment and documentation requirements for effective decontamination of target areas and their validation.
• Working with client representatives to ensure they obtain the correct documentation to achieve goals and certifications required by site.
• Leading or assisting in the development of job-specific, on-site protocols for the validation work to be carried out on client locations.
• Collecting site specific information in preparation of equipment installation and commissioning.
• Maintaining a strong working knowledge of cGMP practices and provide consultation to Bioquell staff on the subject
• Traveling extensively (at least 80% of the time) to domestic and international client sites to execute developed protocols including but not limited to:
• New equipment installation, setup, commissioning
• Equipment integration testing
• Operator training
• Calibration on new equipment
• Troubleshooting new installations on site
• Cycle development services on clients sites for cGMP and non-cGMP facilities
• Equipment performance qualifications
• Reacting to and remedying emergency client requests for information and services in a professional and flexible manner.
• Providing upkeep to validation equipment to ensure it is in safe working condition.
• Participating in departmental cross-training with service and RBDS responsibilities to assist in these roles when necessary.
• Writing and executing material testing protocols as needed for clients requesting this service.
• Handling micro-organisms as an integral part of verification/validation of the decontamination cycle development process.
• Collecting and recording site specific data.
• Generating, reviewing and distributing required site specific reports.
• Following company policies, procedures and business ethics codes.??

Position Details:

• Work Schedule: Monday to Friday, 40 hours a week, including occasional weekend work
• Weekend working may be required
• Security clearance may be required for certain clients

Minimum Qualifications:

• Strong background in science, engineering, math or other technical discipline
• Full understanding of scientific process with strong analytical abilities
• Outstanding technical aptitude for mechanical and electrical assemblies
• Excellent troubleshooting abilities
• Working knowledge of cGMP practices
• Professional, respectful supervisory behaviors and approach
• Willingness to travel (minimum of 80% of time, with possibility of travel abroad)
• Responsible, reliable, quality conscious attitude and commitment to job requirements and performance

Physical Demands:

• Ability to complete pre-employment assessments including a physical, lift and/or carry 50 pounds and drug screen
• Personal protection: Personal protection equipment (PPE) may be worn on customer sites