Engineer, Quality Assurance (Validation)

Location: Oxford, North Carolina

Department: R&D

This role is an Onsite Role: This role requires full-time presence at our Oxford, North Carolina office.

Major Duties:

• People-
  • Develop excellent working relationships with both Oxford peers and management.
  • Mentor and coach team as well as all cross-functional colleagues on process-based root cause problem solving.
• Culture-
  • Drive culture change, to one that is data-driven, fact-based, and quality-oriented, without sacrificing plant capacities and output.
• Quality-
  
  
  • Site Subject Matter Expert (SME) for cleaning process development and validation.
  • Establish and perform carry over limit calculations and determine appropriate carryover limits with documented rational. (As applicable)
  • Support cleaning process development activities for CIP and COP, manual and automated, processes.
  • Prepare detailed plan for coordination and execution of validation activities with various stakeholders (Operations, R&D, QC, etc.) and follow up on validation plans.
  • Responsible for the execution, or supervised execution of associated protocols.
  • Assesses the impact of deviations, CAPAs, and associated change request on the validation status of equipment and/or systems.
  • Author Cleaning Validation Protocols and Reports.
  • Assess changes via NPD, change controls, etc for impact on validated systems (Equipment, Cleaning, Process, etc).
• Delivery/Innovation- New Product Development (NPD) is the driver of our industry’s success. Do what it takes to achieve Ship-to-Trade (STT) dates without sacrificing cGMP compliance, Safety of the end user, and brand Quality expectations.
• Cost-Support directly all assigned cost reduction initiatives. Be aware of the business impact that quality has on cost reduction and suggest projects to achieve plant goals.
• Key Partners-Will need to build solid relationships with all functions of the organization, in particular Corporate QA, plant Quality Control (QC), Regulatory Affairs (RA), R&D Development and Services, Packaging Development and Engineering, Supply Chain, Revlon-owned plant Production, and TPM leaders, both Revlon employees and TPM employees.
• Other duties as assigned.
• Minimal to no travel required

Required Knowledge & Skills

• Minimum of 4 years of relevant experience within the consumer personal care industry and/or pharmaceutical industry. (Pharmaceutical preferred)
• Demonstrated, hands-on experience with cleaning validation activities
• Minimum of a Bachelor’s of Science degree, such as Engineering, Microbiology, Chemistry.
• Experience working in a cGMP environment and good understanding of regulations and industry guidance including but not limited to FDA, Health Canada, EMA, and ICH
• Engaging and motivational personality that enjoys being a part of the team, so that strong, tight-knit, cross-functional teams are built and the culture is changed as needed to drive business growth. Communication and relationship-building is a critical as needed to drive business growth. Communication and relationship-building is a critical skill for this role.
• Experience leading or at least participating in strong culture change using influential leadership skills rather than authoritative practices. People should see the value in what is being driven for change and want to follow.
• Experience leading or participating in auditing activities for cGMP compliance.
• Enjoys learning and development and considers self an emerging Subject Matter expert (SME) on the FDA regulations governing OTC and non-OTC products; prefer to also have experience with ISO 9001, ISO 22716, European regulations, and ICH guidelines.
• Ability to manage time and workload so that the goals and objectives for each role are met, using appropriate prioritization strategies.
• Proficiency in standard business software (Word, Excel, Outlook, PowerPoint)
• SAP experience, or other ERP systems

#LI-AH1

Revlon is unable to sponsor or transfer employment visas for this role; candidates must be legally authorized to work in the United States without current or future visa support.

The base pay range for this position is $70,000.00 - $95,000.00 / year; however base pay offered may vary depending on skills, experience, job-related knowledge, and geographic location. Certain positions may also be eligible for short-term incentives as part of total compensation.

Employees (and their families) are eligible for medical, dental, and vision benefits. Employees are covered by the company-paid basic life insurance policy and company-paid short-term disability insurance (the benefit commences upon hire and allows for a portion of base salary for up to 26 weeks if you are disabled). Other benefits offered to employees include but are not limited to the following: long-term disability, supplemental life insurances, flexible spending accounts, critical illness insurance, group legal, identity theft protection, etc. Employees are also able to enroll in our 401k Retirement Savings Plan.

Employees will also receive 3 weeks of vacation, pro-rated based on date of hire for the 1st year of employment and twelve paid holidays throughout the calendar year. Vacation will depend on role.