Curia specializes in contract manufacturing of liquid and lyophilized small-volume parenteral products using aseptic processing technology to deliver high-quality sterile products to the pharmaceutical industry. Curia offers value-added services to assist customers in developing and manufacturing various sterile products. 

We proudly offer

Generous benefit options (eligible first day of employment)  Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities  Education reimbursement 401k program Learning platform And more! 

The Director of Validation is an essential part of the Quality Management and Site Leadership team. The Director is responsible for the validation program at Curia and will report to the Site Head of Quality. The role will lead and manage validation activities for Curia equipment, facilities, processes, cleaning, computerized systems, and projects (e.g., new product introduction, facility expansion, new line installation, etc.). 

The role will provide a clear vision for validation requirements consistent with cGMPs, regulatory expectations, and industry best practices and will manage the budget and resources to ensure that objectives are met within the timeline and budgetary constraints. The role will ensure that validation personnel are adequately trained, have the necessary skill-set to perform their function, execute validation activities and achieve a compliant validation program supporting a GMP manufacturing facility for sterile injectable products. The role may manage independent contributors and supervisors/managers best to carry out the responsibilities of the validation department. 

The role will establish and maintain cross-departmental relationships that effectively support and increase the overall compliance and profitability of the company. The position determines the direction and prioritization of the validation activities. It will provide input/guidance during the review and approval of regulated, controlled documents, including but not limited to SOPs, validation protocols, commissioning protocols, deviations, change controls, work orders, and validation master plans (i.e., cleaning, facilities, packaging systems, and computer-related systems for Curia).

Essential Duties and Responsibilities include the following:

Develop and continuously improve site validation program including equipment, process, cleaning, sterilization and CSV. Responsible for completing initial qualifications and requalification of facility, equipment, process, cleaning and computer systems Responsible for directing and providing quality leadership within the validation department and cross-departmental leadership and direction at Curia. It is served as a resident quality validation expert and approving authority in support of validation, change control, work orders, and other related documents as the quality approver. Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance.   Responsible for ensuring validated parameters are transferred to routine manufacturing  Responsible for providing guidance and support for site aseptic process simulations  Provide compliance direction and leadership to the validation department and company-wide in establishing validation strategies based on industry best practices and regulatory expectations. Provide validation impact assessments for facility, utility, and equipment changes and input related to product technology transfers to the facility. Serve as the validation liaison and SME by providing technical reviews on new product opportunities, including new equipment and technology.  Coordinate validation activities with section supervisors to ensure timeliness with minimal disruption to production and facility shutdown schedules. Direct validation process improvements and goals for Curia using current regulations and demonstrated best practices. Serve as the validation liaison between the site and customers or regulatory agencies during facility audits/inspections. Support effective and efficient continuous quality and cost improvement efforts. Hire, train, and develop staff and conduct performance reviews to assure highly effective, team-oriented contributors to Curia's success. Other duties may be assigned. 

Supervisory Responsibilities :                                                       

Validation Director directs, coordinates, and evaluates staff within the validation department and carries out supervisory responsibilities following the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Education and Experience: 

Bachelor's degree (BS or BA.) in a scientific or related field from a four-year college or university and 10 years of progressively greater responsibilities in the pharmaceutical products/medical devices industry, including validation, regulatory compliance, and quality; and relevant experience in change control and validation activities; with a minimum of five (5) years in a validation leadership role. They will demonstrate an understanding of laboratory, manufacturing, packaging, regulatory affairs, compliance, and quality assurance requirements for biological and drug manufacturing. Experience strongly preferred working with third-party contract manufacturing in the Pharmaceutical industry.

Other Skills and Abilities:                                                 

Direct and manage the validation function. Direct and lead the validation staff at the Curia facility. Facilitate mandatory reviews of SOPs and month-end reports.  Provide quality oversight and approval for validating processes, utilities, facilities, and equipment. Provide quality validation oversight to facility, utility, and equipment upgrades. Review and approve qualification, validation, re-qualification, and re-validation documents for equipment and manufacturing process protocols, deviations, and final report. Coordinate and prioritize validation activities. Ensure the Writing, updating, and maintaining of pertinent validation master plans for the facility. Ensure the Writing, updating, and strengthening of relevant validation technical packages for product submissions.  Communicate with clients regarding changes to facilities, processes, and procedures. Provide plant management with data and information appropriate to reduce the potential for regulatory action and assist in Curia productivity management. Keep plant management advised concerning agency, customer, and internal audit compliance commitments.  Provide training on quality systems, especially related to validation and cGMPs. Provide technical expertise and internal technical consulting within Curia's facility. 

Other Qualifications:

Must pass a background check & a drug screen Knowledge of technical Writing and technical terminology, including technical writing skills. Ability to assess and communicate regulatory risks. Knowledge of aseptic processing and regulatory and industry guidelines and requirements.  They can train and advise validation professionals and production personnel. Ability to manage and lead staff, as well as address the requirements of the function itself. Knowledge of cGMPs, GDPs, sound quality, and regulatory principles consistent with "best practices."    They demonstrated knowledge of plant quality systems, plant data systems, preparing responses to audit observations and deviations, and corporate metric systems. Leadership qualities are required. Attention to detail is required.  Ability to read, understand, interpret, and apply technical Writing and instructions. Good verbal and written communication skills. Visual acuity.             

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and perform any other job-related duties requested by anyone authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to accommodate individuals with disabilities reasonably. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.