Manager, Validation; Quality Assurance in Renesselaer, NY.

　　Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

　　The Validation Manager is an essential part of Quality’s management team. The Validation Manager will assist in management of the daily activities of the Validation Department. The Validation Manager will be responsible for overseeing the validation activities of the site, review of applicable change controls for impact to validation criteria as well as maintenance activities associated with validated equipment and systems. The Validation Manager will revise the essential validation documents including the Validation Master Plan(s).

　　Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

　　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!

　　Summary:

　　The Validation Manager will work with other departments to make sure the risk assessment, IQ, OQ and PQ activities associated with new components, equipment (including laboratory testing equipment), systems, and utilities are performed according to established schedules, user requirements and needs. This position leads the department in actions related to new product introduction. This position is also responsible for managing the activities of the Validation Department in terms of equipment re-qualification schedules and associated activities during facility shutdowns, and ensuring the plant is in a ready state to manufacture product after shutdown activities have been completed.

　　Supervisory responsibilities:

　　Directly supervises employees in the Validations Department. This role carries out supervisory responsibilities in accordance with 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.

　　Essential job duties:

　　Responsible for providing leadership for the Validation Department at the facility

　　Ensure change controls, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP)

　　Coordinate validations with section supervisors to ensure timeliness with minimal disruption of production schedules

　　Review and write validation protocols, final reports, and summaries of work for release of equipment tested

　　Perform the usual duties of a manager such as develop annual goals and objectives for department; develop, implement and manage annual operating budget; approve expenditures; monitor staffing; address employment issues; ensure compliance with regulations and policies; and manage the overall functions of the Validation area

　　Serve as validation liaison between the site and customers or regulatory agencies during facility audits and provide audit support by presenting validation activities

　　Provide leadership and guidance to staff in the performance of their duties. Manage performance objectives, scheduling, hiring, performance evaluation, etc.

　　Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance

　　Review and approve qualification, validation, re-qualification, and re-validation documents for equipment and manufacturing process protocols and final report

　　Coordinate and prioritize validation activities at the facility

　　Write, update, and maintain pertinent Validation Master Plans for the facility

　　Develop annual goals and objectives for department and manage the overall functions of the Validation area

　　Approve validation protocols for all equipment/systems

　　Review and approve cleaning validation, facilities cleaning validation, packaging system validation, and computer-related system Validation Master Plans

　　Review and approve validation protocols for computer related systems (as needed), environmental monitoring (if applicable), and process validations

　　Participate in the review of changes made under the Change Control System from a validation perspective

　　Departmental Housekeeping:

　　Provide validation oversight to facility, utility and equipment upgrades

　　Provide validation input to technology transfers

　　Author, review, or approve impact assessments prepared by the Validation Department for change controls

　　Review and revise SOPs as needed for approval

　　Directly understand and implement safety procedures and cGMP

　　Develop and execute plans for growing individuals within the Validation Group

　　Provide plant management with data and information appropriate to reduce potential for regulatory action and assist in site productivity management

　　Provide information to customers on validation activities and improvement plans, as needed

　　Education, experience, certification and licensures

　　Education: BS/BA in Engineering, Chemistry, or Life Sciences and

　　Manager: minimum 7 years of experience in Quality and Validation of pharmaceutical, API or relevant fields and at least 3- 5 years process validation or equipment qualification experience

　　Experience leading, supervising, or managing others required

　　Knowledge, skills and abilities

　　Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations

　　Ability to write reports, business correspondence, and procedure manuals

　　Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

　　Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry

　　Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations

　　Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists

　　Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

　　Knowledge of database; Internet, spreadsheet, and word processing software

　　Pay Range:

　　$97,000 - $121,300

　　Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

　　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.

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