Engineer, Quality

3 weeks ago

Oxford, United States Revlon Full time

** Engineer, Quality (Cleaning Validation)**

**Job Category****:** PR2 Scientific Prof **Requisition Number****:** ENGIN007262 Showing 1 location **Job Details**

**Description**

Overview:

* Act as an SME regarding the total lifecycle of key validation efforts, this position will carry out the commissioning, qualification, and validation of equipment, systems, and processes, with the primary focal point associated with cleaning.

* This role will drive culture change in the organization to that of a harmonized, consistent Quality System and expectation.

* No Direct reports.

**Responsibilities:**

* **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 industrys 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.

**Experience:**

* 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 Bachelors 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.

**Knowledge, Skills and Abilities:**

* 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 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-KD1

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

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