QA CSV/CQV Specialist

Job Title: QA CSV/CQV Specialist
Location: Rahway, NJ (On-Site: 4 days; Remote:1 day)
Eligibility/Clearance: Must be authorized to work in the US

Job Description:

Seeking a talented and driven individual to join our Quality Assurance
Computer System Validation (CSV) team, for the launch of a new building
at Rahway NJ site. The candidate will play a pivotal part in ensuring
the compliance and efficiency of computerized systems within the new
facility, contributing to the successful implementation of our
operations. This role presents an exciting opportunity to be part of a
dynamic team and make a significant impact on the quality and
reliability of our systems in a cutting-edge environment.

Primary Responsibilities:

-Responsible for providing quality assurance support and oversight for
commissioning/qualification of the facilities, equipment and instruments
in the manufacturing facility and the associated laboratories.

-Responsible for providing quality oversight for automation systems for
new facilities and upgrades to the existing facilities. Automation
systems include systems such as Delta V, BAS, BMS & SCADA.

-Responsible for quality oversight cleaning and thermal validation.

-Responsible for the review and approval of SOPs.

-Provide Quality support for Environmental Area and Utility Performance
Qualification Plans, Protocols and Reports.

-Quality ownership for new capital projects which can include new
facility associated utilities and equipment.

-Leading routine process support and improvement activities.

-Providing Quality guidance for daily production support, projects,
deviations, and changes.

Position Qualifications:

Education Minimum Requirement:

-B.S. and/or M.S. degree in an appropriate Life Science, Computer
Science, Information Technology or Engineering discipline.

Required Experience and Skills:
-At least 10-15 years of experience working in a
Pharmaceutical/Biotechnology industry experience working in a health authority regulated (e.g. GxP)
environment.

-Industry experiences including computer system validation, System Life
Cycle (SLC), software validation, and/or Quality Assurance functions.

-High level of expertise and exposure with agency regulations, such as
21 CFR Part 11

-Part 58, Part 210, Part 211 from the US Food and Drug Administration.
-Experience in creation, execution, and reviewing change control
document.

-Strong interpersonal and written/oral communication skills.

-Ability to quickly process complex information and often make critical
decisions with limited information.

-Proficient in applying process excellence tools and methodologies

-The candidate must be highly organized and capable of working in a team
environment with a positive attitude under some supervision.

-Good written and verbal communication skills are required.

-Ability to work with others in a team environment.

-Experience authoring and executing documentation including but not
limited to: Batch Records, SOPs, Work Instructions, CQV protocols.

-Experience with TrackWise, CMMS and Maximo

-Proficient with using Microsoft Office applications (Outlook, Excel,
Word, and Powerpoint)

-Experience working in an aseptic manufacturing facility, quality
testing facility, quality assurance, or manufacturing compliance.

-Demonstrated ability to work independently, drive effective
communication, coordination and collaboration across relevant cross
functional groups to establish a strong, compliant CQV program.

Preferred Experience and Skills:

-Experience with Project Management principles

-Expertise with end-to-end data governance

-Knowledge of published regulatory agency data integrity, computer
software assurance

guidance.

Arena Technical Resources, LLC, (ATR) is an Equal Opportunity Employer
(EOE) who will provide equal employment opportunity to employees and
applicants for employment without regard to race, ethnicity, religion,
color, sex, pregnancy, national origin, age, veteran status, ancestry,
sexual orientation, gender identity or expression, marital status,
family structure, genetic information, or mental or physical disability.