Sr. Engineer, Cleaning Validation

Hikma Pharmaceuticals; Columbus (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) program with company match

Generous paid time off

Comprehensive health benefits

Tuition reimbursement

Job summary

Hikma Pharmaceuticals in Columbus, OH is seeking a Sr. Engineer, Cleaning Validation. This role involves developing and approving validation deliverables, conducting reviews of cleaning processes, and training colleagues. Candidates should have a Bachelor's degree and significant experience in the pharmaceutical sector.

The position offers full-time employment along with comprehensive benefits including performance bonuses, 401(k) match, and generous PTO. The ideal candidate will possess strong project management skills and a proven ability to handle multiple priorities.

Qualifications

• Minimum of eight years of pharmaceutical industry experience.
• 5+ years specific cleaning validation experience in a pharmaceutical environment.
• Ability to collect, statistically analyze, and interpret data.
• Demonstrated proficiency in technical writing.

Responsibilities

• Develop and approve validation deliverables.
• Conduct periodic reviews of cleaning processes.
• Revise and approve cleaning procedures and documentation.
• Lead training of Cleaning Validation colleagues.

Skills

Statistical analysis

Technical writing

Project management

Interpersonal communication

Attention to detail

Education

Bachelor’s degree in engineering or related scientific discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Change control system

SAP

Document Management system

Laboratory information system

Job description

Job Title: Sr. Engineer, Cleaning Validation

Location: Columbus, OH

Job Type: Full time

Req ID: 10915

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

• 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.

Benefits

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre‑tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

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.