Plant Engineer GMP - Pharmaceutical

Plant Engineer GMP - Pharmaceutical

Newark, CA

Job Summary

Our client is on a mission to disrupt the biotechnology industry with forward-thinking technology that powers the patient care experience. With a strong legacy as a biotechnology R&D house, the company is focused on delivering innovative aesthetic and therapeutic products that provide exceptional, meaningful outcomes to consumers. Come be a part of our journey in setting a new standard. 

The Plant Engineer GMP participates in design review and implementation for all projects, process engineering, refurbishment/replacement and life cycle cost analysis for the Drug Substance/Drug Product process and equipment. The successful candidate provides engineering support for drug substance related maintenance, engineering and calibration management programs. This position troubleshoots operations of the process & facilities equipment and utilities as needed. The Plant Engineer develops, establishes, and maintains quality-engineering methodologies, systems, and practices which meet internal and regulatory requirements. This position also provides focused quality engineering support for the Facilities department on new construction, facility upgrades/retrofits/modernizations, and facilities equipment. 

Essential Duties/Responsibilities

• Perform design review and construction management for projects

• Perform in-house design and manages facilities engineering and construction projects

• Manage the installation and repair of infrastructure of Drug substance and Drug product process equipment as well as related environments. This includes fillers, cappers, Lyophilizers, closed RABs, vial washers, inspection and labeling equipment

• Support the installation, maintenance, operation, and adjustments made to the process equipment, and related utilities such as pumps, boilers, air handling units, air compressors, chillers, clean steam, and USP Purified Water systems

• Collaborate with manufacturing departments to ensure compliance activities are executed efficiently and effectively, and in accordance with all governing documents and regulatory guidelines

• Serve as a subject matter expert (SME) in support of drug substance and drug product related facilities equipment and projects

• Develop, mentor, and train personnel and internal customers on relevant business processes

• Contribute to continuous quality improvement efforts to conform to regulatory requirements and industry standards.

• Track, trend and analyze utility data

• Support negotiations and management of technical facility maintenance contracts

• Support management and oversight of scheduled preventative maintenance on a wide variety of process equipment and support utilities

• Cross Train in-house staff on facilities and process equipment operation & maintenance

• Perform related duties of a similar nature and complexity as required

• Liaison between engineering, manufacturing and quality to identifying and resolving quality and compliance related issues

• Identifies and implements effective commissioning and validation, and support the development, qualification, and ongoing quality support of facilities to meet or exceed internal and external requirements

• Act as an effective team member in supporting quality disciplines, decisions, and practices

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

• Assure the development and execution of streamlined quality systems for the team, which effectively identify and resolve quality issues 

Education

Minimum Required: B.S. in Related engineering field

Experience

Minimum Required:

• HVAC and clean utilities design or installation experience
  required to occasionally wear personal protective equipment including respiratory protection equipment

• Aseptic formulation and filling manufacturing experience required

• Ability to work independently and cross-functionally in a dynamic environment

• Ability to draft, edit and complete required qualification and engineering documents

Knowledge, Skills and Abilities

Minimum Required:

• Must have working knowledge of biological processes, equipment, and facilities. Experience with potent compounds or CDC Select Agent and Toxin regulations a plus

• 5-8 years’ experience in a GMP regulated environment

• Must have exceptional written and oral communication skills

• Must be familiar with the Microsoft Office suite of products

WORK ENVIRONMENT & PHYSICAL DEMANDS

This section of the job description is required by the American with Disability Act, (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

• Prolonged periods of sitting at a desk and working on a computer

• Must be able to lift up to 10 pounds at times