Senior CSV Systems Engineer

Senior CSV Systems Engineer in Albuquerque, NM

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

The Senior CSV Systems Engineer is an integral part of the Curia Quality team. This position will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections.

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!

Supervisory Responsibilities

This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

Responsibilities:

• The primary responsibilities of the CSV Engineer-II, are to ensure that routine tasks supporting the validation of electronic systems and applications supporting commercial drug product manufacturing, are documented in accordance with the relevant company procedures and health authority regulations

• Shall be able to generate and execute validation documents, to ensure the system(s)/software are maintained in the most current validated state per regulatory requirements

• Assist cross-functional team in identifying the required validation deliverables for new systems/software/equipment or changes to existing validated systems/software/equipment

• Assist cross-functional teams in completing system/equipment impact assessments, electronic record and electronic signature assessments

• Perform gap assessments on vendor executed protocols, ensuring compliance to current regulations are met and maintained

• Collaborate across functional areas across the organization to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes

• Provide guidance/support during specification (URS, FS, DDS or CS) document generation and review

• Shall ensure that all required Software/System Development Lifecycle Documents are available for regulatory and client audits, and participate as needed in site audits.

• Develop and execute CSV change records (Change Controls), CAPAs and Quality events for CSV projects

• Act as investigator on any CSV Deviations

• Support Site CSV actions resulting from client/regulatory audits

• Participate as site SME in site audits /inspections

• Provide guidance on quality issues that affect the integrity of data or system validation

• Maintain accurate inventory of all applications, hardware, and computer systems within the Curia Albuquerque site

• Ensure all computer systems have up to date Antivirus software and backup software installation

• Update computer systems that are running outdated Operating systems

• Investigate failed backups and investigations

• Execute periodic reviews

• Provide routine project status reports

• Provide routine software and hardware inventory updates

• Provide routine progress updates on SOPs and Templates

• Provide CAPA, QE and CR updates to compliance team

• Provide routine audit observations and remediation

• Ability to work at elevated heights

• Read/interpret SOPs to ensure compliance

• Maintain up to date trainings

• Other duties as assigned

Required Qualifications:

• Provides guidance and mentorship to team members

• Fosters a collaborative and positive work environment

• Champions change

• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.

• Demonstrates strong attention to detail

• Ability to adapt to changing circumstances and manage activities to meet the needs of the business while maintaining a focus on quality and information assurance.

• Solid knowledge of FDA and applicable global regulations

• Demonstrate a proactive approach to Computer System Validation

• Possess excellent leadership and management skills

• Ability to adjust quickly to shifting priorities, and decision-making skills with limited information

• Highly motivated individual with the ability to self-start, prioritize, multi-task, and has a "can-do" attitude

• Ability to communicate and work effectively with others, harness different skills and experience, and build a strong sense of team spirit

• Excellent verbal communication, and interpersonal skills to document and communicate findings, escalate critical risks to stakeholders

Education and Experience:

• Bachelor's degree in Engineer, Life Science, Information Technology or related field

• Minimum of seven (7) years' experience working in a cGMP regulated industry specific to computer systems validation

• Validation experience in a cGMP quality control laboratory or sterile fill finish operations, developing and executing SDLC documents that meet current regulatory and industry expectation, preferred.

Other Qualifications:

• Must pass a background check

• Must pass a drug screen

• May be required to pass Occupational Health Screening

• May be required to obtain and maintain gowning certification

• May be required to obtain and maintain media qualification

• May be required to wear a respirator

Language Skills:

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical Skills:

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Physical Demands:

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.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, 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.

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.

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 ~~~ 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.