Validation Specialist II at Curia

City of Rensselaer, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jul, 26

Salary

0.0

Posted On

03 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation, Technical writing, cGMP, Temperature mapping, Temperature monitoring, FDA regulations, EU regulations, Pharmaceutical industry, Standard operating procedures, Protocol execution, Preventive maintenance, Calibration, Quality assurance, Data analysis, Regulatory compliance

Industry

Pharmaceutical Manufacturing

Description

Validation Specialist II in Rensselaer, NY Build your future at Curia, where our work has the power to save lives Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives. 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 with matching contributions * Learning platform * And more! Position overview The Validation Specialist II assists with the validation activities throughout the plant, coordinates appropriate support and assists in completing validation activities and provides technical assistance to Engineering Services, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Essential job duties 1. Develop and write Standard Operating Procedures for new processes and equipment, in conjunction with the system owners 2. May interact with outside vendors and consultants as needed 3. May author and/or execute required protocols and complete reports for equipment, process utility, test, and software validations and revalidations for validation equipment as assigned 4. Support department projects by assisting senior engineers with ongoing projects 5. Understand and implement safety procedures and cGMP 6. Support internal and external audits by providing data appropriate to the investigation as required 7. Keep department management and personnel aware of engineering-related issues that may have a regulatory compliance or financial impact 8. May perform Preventive Maintenance and Calibration tasks as required following existing procedures Education, experience, certification and licensures Required · Bachelor’s degree in Engineering, Science or related field · Minimum 3-5 years’ experience in the pharmaceutical industry Preferred · Advanced degree in Engineering, Science or related field Knowledge, skills and abilities 1. Familiar with validation tools and processes, including temperature mapping and/or temperature monitoring equipment 2. Familiar with FDA and EU regulations for pharmaceuticals and medical devices 3. Strong technical writing skills are required to author validation documentation 4. Ability to work semi-independently; demonstrated ability to interact well with other technical departments 5. Excellent verbal and written communication skills 6. Working knowledge of internal standards for written communications as they apply to controlled document changes/revision Physical requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. Work environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate. Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials. Pay Range: Education, experience, location and tenure may be considered along with internal equity when job offers are extended. 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. 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

Responsibilities

The Validation Specialist II assists with validation activities throughout the plant and provides technical support to Engineering, R&D, Production, and QA/QC departments. They are responsible for writing standard operating procedures, executing validation protocols, and ensuring compliance with safety and cGMP standards.