Process and Equipment Validations Engineer

Unfortunately we are not able to offer any work Sponsorship for new employees at this time.

JOB SUMMARY:

Nucleus Biologics™, The Cell Performance Company™, is the leading provider of custom cell-growth media, tools, and technologies for cell and gene therapy. Our mission is to speed the time from scientific discovery to cure by delivering innovative, transparent and cGMP products and services with the goal of disrupting the market and eliminating antiquated practices and products. We have multiple state-of-the-art facilities where we manufacture our products. This individual will also be responsible for building a culture of continuous improvement and developing all personnel to create professional growth opportunities. We are looking for a proven performer who is a deliberate and intelligent performer. This position will report to the Head of Technical Operations.

II. RESPONSIBILITIES:

Equipment Qualifications (IQ/OQ/PQ)

· Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.

· Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.

· Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.

· Develops and maintains databases for tracking test results, validation activities, or validated systems.

· Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices.

· Modifies testing methods or revisits test objectives and standards to resolve testing problems.

· Calibrates equipment to ensure accurate measurements.

Manufacturing Process Validations

Generate and sustain Verification/Validation protocols (I/OQ, PQ) and related technical documents to support the transfer of processes into Production.

Assist in failure investigations and root cause analyses as they relate to process performance.

· Identifies nonconformities of product or process standard and offers recommendations for resolving deviations.

Have fun and contribute to a winning culture

III. REQUIREMENTS:

EDUCATION:

· BS in engineering or other technical field

· 3-5+ years of experience in a GMP or ISO 9001/13485 environment

KNOWLEDGE AND EXPERIENCE:

· Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.

· Proven experience with DOE’s, root cause analysis, process engineering, and failure investigations

· Excellent verbal and written communication skills.

· Familiar with statistical process control methods.

SKILLS AND ABILITIES:

· Strong experience working in cGMP and/or ISO 13485 environments

· Knowledge of cGMP manufacturing, cell culture, aseptic processing and process validations

· Experience developing and executing IQ, OQ and PQ documentation for GMP equipment.

· Ability to independently develop and manage projects and timelines

· Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships

· Strong attention to detail

· Ability to exercise independent judgment consistent with Company guidelines

· Strong process mindset

PROBLEM SOLVING AND DECISION MAKING:

· Develops solutions to a variety of complex problems; ensures solutions are consistent with organization objectives

PHYSICAL REQUIREMENTS:

· Ability to hear and speak to employees and external associates on the phone and in person.

· Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)

TRAVEL REQUIREMENTS:

· May require travel to and from Nucleus Biologics offices or customer/vendor locations

NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.