Title:  Sr. Engineer, Equipment Validation

Job Title: Sr. Engineer, Equipment Validation

Location: Columbus, OH

Job Type: Full-Time

Req ID:7108

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

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 T Sr. Engineer, Equipment Validation to join our team. 

In this role, you will be directly responsible for the management and execution of all validation activities related to production and/or facility equipment though a range of project sizes and complexities.

Provide project support and guidance on small and large scale validation/qualification initiatives to internal project teams to ensure project deliverables are met. Ensure equipment systems are in compliance with regulatory requirements through maintaining change control process and conducting periodic reviews. Investigate / make sound recommendations for validation compliance concerns or new regulations and support regulatory inspections by taking an active role in the process

Key Responsibilities:

Serve as project manager for validation/qualification aspects of complex projects in targeted areas that could be multi-faceted (potentially >$1M). Lead development of validation strategy to ensure regulatory guidelines are followed relative to the equipment validation topic. Identify and procure contract validation services when required, including development of requests for proposals, proposal/contract review, coordination of approvals, and interface with contract service personnel in the oversight of the validation activities to make certain resources are available to meet validation project deliverables. Direct task assignment, schedule development, evaluation of procedure adherence, and proper documentation archival.

Author validation plans and oversee the development of specifications (user requirements, functional requirements, and design requirements), trace matrices, validation summary reports and test protocols for installation, operation, and performance under the guidance of the department manager or designee. Provide direction on Equipment Change Control development in accordance with appropriate procedures.

Lead the maintenance of assigned system validation state by developing, approving, and monitoring proper testing as part of the change control program. Perform or oversee periodic reviews of systems to monitor the validation status of systems and execute necessary actions to close gaps discovered through the process. This includes review and analysis of change controls, review of equipment documentation, and review of other equipment procedures and processes.

Take a leadership role in the development and modification of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for equipment validation policies, standards, procedures, and templates (including test cases). Investigate and identify industry trends in validation and expectations of regulatory agencies and modify the program as appropriate to align with current requirements. May provide regional or global support on procedures, best practices, or continuous improvement projects related to equipment validation.

Develop and coordinate ongoing guidance and training of site personnel on policies and procedures related to equipment validation, including requirements, best practices, and lessons learned. Mentor and train colleagues on policies and procedures, including the requirements for validation.

Qualifications

• Bachelor’s Degree Engineering, or related scientific discipline

• In lieu of a bachelor's degree, an additional four years of experience is required in the below areas of engineering.
• 5+ years of experience in areas of validation, qualification, or commissioning, preferably in the chemical, food, or pharmaceutical industries.
• Experience with the authoring and execution of documentation including validation documentation, technical protocols and/or technical reports preferred.
• Demonstrated ability for independent work that requires multi-tasking and a high level of attention to detail.
• Demonstrated ability or ability to facilitate and/or be an active participant on teams.
• Demonstrated successful communication and negotiation skills in order to manage conflicting and/or multiple demands, including ability to present to various level within an organization.
• Demonstrated knowledge of project management skills and techniques, ability to prepare time lines and schedules to ensure projects are executed on time and within budget.
• Experience working with validation and construction contractors to facilitate project deliverables.
• Knowledge of FDA Current Good Manufacturing Practices (cGMP), GAMP 5 requirements.
• Experience and Inspection interaction with FDA, EMA or other regulatory agencies preferred.
• 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.
• Willingness to travel to external domestic and international supplier sites (typically less than 10% of the time).
• Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, SAP preferred.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% 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.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.