Sr. Engineer, Cleaning Validation

Job Title:      Sr. Engineer, Cleaning Validation

Location:      Columbus, OH

Job Type:     Full time

Req ID:         10915

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Sr. Engineer, Cleaning Validation to join our team.  

In this role, you will be responsible for developing, maintaining, and approving the cleaning validation requirements ensuring compliance to the applicable business and regulatory standards. Develop and maintains site cleaning and cleaning validation processes from product development through product lifecycle. Review and approve the cleaning procedures and support the process to educate those performing the cleaning on the expectations and intent of cleaning, inspection, and cleaning verification sampling. Defines testing strategies and document the performance and compliance of the cleaning validation program. Interfaces with regulatory inspections, investigations and site projects.

Key Responsibilities:

• Develops and approves validation deliverables, which comply with regulatory guidelines and business requirements. Represent CV during regulatory inspections.

• Conduct periodic reviews of the compliance of cleaning processes to the validated state and to ensure the effectiveness of the cleaning validation program.
• Revise and approve procedures for cleaning processes utilized in operations including cleaning, inspection, and cleaning verification work instructions.
• Support the implementation of the optimization and improvements in a consistency and effectiveness ways of cleaning processes.
• Support employee training to ensure compliance to procedure and process effectiveness. 
• Establishes and/or participates in the creation of policies, procedures, guidelines, and templates in the area of validation. Provide leadership and direction to manage the testing approach and cleaning swab sample locations on new equipment and/or for new products, with the appropriate direction on the alignment with the philosophy defined by the Cleaning Validation engineering team.
• Lead, define and manage the mentoring and training of Cleaning Validation colleagues on policies and procedures including the cleaning validation process.

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: 

• Bachelor’s degree in engineering or related scientific discipline.
• Minimum of eight (8) years of pharmaceutical industry experience in quality, production, engineering or a laboratory setting.
• 5+ years specific cleaning validation experience in a pharmaceutical environment. Three years of that experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable.
• Experience with the authoring and execution of Quality documentation including validation documentation, technical protocols and/or technical reports. Strong knowledge of FDA Current Good Manufacturing Practices (cGMP), ISPE's Risk-Based Manufacture of Pharmaceutical Products, and ICH Q9 Quality Risk Management. Experience and Inspection interaction with FDA, EMA or other regulatory agencies required.
• Ability to define a problem; collect, statistically analyze, and interpret data; contribute to development of corrective and preventative actions (CAPA) and implementation plans.
• Demonstrated knowledge of project management skills and techniques, ability to prepare time lines and schedules to ensure projects are executed on time. Excellent organization skills with demonstrated ability to manage multiple projects and deadlines simultaneously. Self-directed individual.
• Demonstrated skills in multitasking in an environment of high volume projects. Proven ability to shift thought processes quickly and accurately from one project to another.
• Demonstrated ability to apply critical thinking skills to identify problems. Experience is preferred to use the statistical analysis of data and trends to recognize symptoms, causes, and alternate solutions and makes timely sound decisions even under risk and uncertainty.
• Demonstrated ability for independent work that requires multi-tasking and a high level of attention to detail.
• Demonstrated ability to facilitate and/or be an active participant on teams.
• Demonstrated proficiency in interpersonal communications, both written (technical writing required) and verbal.
• Demonstrated successful communication/collaborative skills, influencing skills, and negotiation skills to manage conflicting and/or multiple demands, opinions, and expectations including ability to facilitate meetings as well as present to various levels within an organization.
• Demonstrate the ability to influence/persuade individuals to gain acceptance of an idea or plan is preferred.
• Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Change control system, SAP, Document Management system or Laboratory information system required.

Preferred Qualifications:

• 3+ years related experience in project or people management role preferably in a regulated environment. 
• Quality experience in the pharmaceutical industry.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.