Associate CQV Engineer Analyst - 3855MC

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Verista is currently seeking Validation Engineers with experience in facilities, equipment and process validation within a pharmaceutical or biotechnology manufacturing environment to support CQV (Commissioning, Qualification & Validation) activities.

This role requires onsite work in Princeton, NJ.

Typical Responsibilities Include:

• Perform Equipment Validation Maintenance Quality Systems review and re-qualification activities to
  ensure GMP equipment is continuously maintained in a validated state.
• Execute and oversee the execution of approved protocols and coordinate the activities with other
  departments including the equipment owner. This element is critical for this role and expierence with
  executing IOPQ of all types of GMP equipment is required.
• Involvement with customer audits and responding to audit observations and corrective actions.
• Assist in investigations of manufacturing / facility deviations.
• Address implications of equipment/facility/procedural Change Controls and Curative and Preventive
  Actions (CAPAs) that impact the business.
• Provide technical support when reviewing and approving SOPs, protocols, change controls, deviations.
• Program, organize, and maintain Validation equipment and supplies.
• Demonstrate a general understanding of cell therapy manufacturing equipment and validation
  procedures for Clean Rooms, Aseptic Processing, Autoclaves, Clean Utilities, Temperature Mapping
  Controlled Storage Rooms and Equipment. Develop validation protocols from Validation plans and
  engineering documents.
• Act as a Subject Matter Expert (SME) in audit and client visits.
• Communicate and assist with management of 3rd party validation service providers if needed.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in Science or technical discipline intermediate or more years of industry experience 4 to 6 years relevant Validation experience, preferably working within an FDA regulated manufacturing facility.
• Good understanding of cell therapy manufacturing equipment and validation procedures for Clean
  Rooms, Aseptic Processing, Autoclaves, Clean Utilities, Temperature Mapping Controlled Storage
  Rooms and Equipment.
• Solid technical writing skills and ability to document all work in a meticulous, accurate, and timely manner.
• Solid written and oral communication skills and ability to work interdepartmentally with some basic
  supervision in an effective manner to carry out daily duties.
• Understand how to write discrepancies and give a root cause analysis.
• Solid organizational and time management skills
• Demonstrates ability to prioritize tasks as needed to support the changing business demands.
• Demonstrated knowledge of procedures, documentation practices, GMP’s and regulations associated
  with the manufacture of bio-pharmaceuticals.
  

Physical Demands

While performing the duties of this job, the employee is frequently required to walk, stand, sit, talk, and hear. Occasional lifting is required of up to 30 - 40 lbs.

Work Environment

Work will occur in the following environments: office, laboratory, environmentally controlled production suites
(ISO 7 & 8), and warehouse.

Benefits

Why Verista?

• High growth potential and fast paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company paid medical premiums.
• Company paid Life, Short-Term, and Long-Term Disability insurances
• Dental & Vision insurances
• Health Savings Account
• 401(k) Retirement Plan