Validation Specialist II

Curia • City of Rensselaer, NY

9h

About The Position

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.

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.

Requirements

• Bachelor’s degree in Engineering, Science or related field
• Minimum 3-5 years’ experience in the pharmaceutical industry
• Familiar with validation tools and processes, including temperature mapping and/or temperature monitoring equipment
• Familiar with FDA and EU regulations for pharmaceuticals and medical devices
• Strong technical writing skills are required to author validation documentation
• Ability to work semi-independently; demonstrated ability to interact well with other technical departments
• Excellent verbal and written communication skills
• Working knowledge of internal standards for written communications as they apply to controlled document changes/revision

Nice To Haves

• Advanced degree in Engineering, Science or related field

Responsibilities

• Develop and write Standard Operating Procedures for new processes and equipment, in conjunction with the system owners
• May interact with outside vendors and consultants as needed
• 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
• Support department projects by assisting senior engineers with ongoing projects
• Understand and implement safety procedures and cGMP
• Support internal and external audits by providing data appropriate to the investigation as required
• Keep department management and personnel aware of engineering-related issues that may have a regulatory compliance or financial impact
• May perform Preventive Maintenance and Calibration tasks as required following existing procedures

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees