Manager, QTO Cleaning Validation/Process

OVERVIEW

This position is responsible for managing, developing and implementing cleaning validation processes and strategies to ensure equipment is visibly, chemically, and microbially free from drug product residue. Responsible for managing, developing and implementing validation processes to ensure that equipment, components, process and products meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices.  Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements.  Position focuses on equipment cleaning processes and process system validation. Responsible for growth and development of Hikma staff for cross-functional training, knowledge, and expertise.

 

RESPONSIBILITIES

 

incumbent will schedule, plan and manage validation projects including: new facility planning and construction of compounding equipment/facilities including selections, acquisition, installation and use; facility/system/process improvements, modifications and additions; new product/process material qualifications, batch size modifications/room transfers, computer-based systems and software as applicable.

 

• Select, develop and retain team.
• Define and communicate criteria by which team and individual success will be measured.
• Provide constructive feedback and recognition.
• Effectively coach, mentor and motivate others for optimal performance.
• Responsibilities also include oversight for the development, completion, approval, logging and archiving of Validation protocols and reports.
• Responsibilities may also include directing or participating in: performing technical failure analysis of processes/product not meeting specifications, investigate/address and reporting on trends to reduce product/process variability
• Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to product and process validation / manufacturing to ensure compliance in all manufacturing efforts.
• Develops and administers budgets, schedules and performance requirements.
• Coordinates activities of personnel in other departments and contractors as well as providing day to day guidance to the Validation staff.
• Acts as advisor to subordinates to meet schedules and/or resolve technical problems.
• Participates in developing Divisional procedures and guidelines and developing responses to corporate, regulatory and third party audits findings.

 

QUALIFICATIONS

 

Minimum of a BS in the Engineering/Math/Chemistry or other job-related discipline.  A minimum of 8 years related experience in validation within a pharmaceutical, biotech or related industry. Minimum supervisor/management experience of 2 years. Masters degree not required but considered a plus.

• Requires excellent analytical skills with systematic approaches to problem solving.
• Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
• Must be able to identify subtle discrepancies in processes or products and have good judgment in determining impact and potential risk.
• Capable of analyzing and solving complex problems through innovative thought processes and experience, as well as, project management tools.
• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Able to manage multiple cross-functional teams simultaneously.
• Must demonstrate effective supervisory/leadership skills.
• Proficient in Microsoft Word and Excel, computer software.
• Sound industry knowledge, project proficiency, and autonomy expected.
• May be considered a Subject Matter Expert (SME) in various disciplines.
• Hands on support for validation execution when required. Must be able to work in Compounding/Clean room environments as applicable.

 

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

 

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.