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Senior Engineering Specialist

2 months ago

Thousand Oaks, California, United States BioSpace, Inc. Full time
Position Overview

HOW WILL YOU INNOVATE?

As a dedicated professional, you have reached a pivotal point in your career and are prepared to elevate your contributions. At BioSpace, Inc., our collective mission to enhance patient care is at the forefront of our operations. This commitment is essential to our standing as a leading entity in the biotechnology sector, impacting millions of lives globally. Join a team of innovative and passionate professionals in this significant role.

Senior Engineering Specialist
Role Description

In this crucial position, the Manufacturing Clinical Supply (MCS) Facilities and Engineering division is in search of a driven Senior Engineer to deliver project engineering assistance across Drug Product, DP Assembly, and Synthetics sectors. The selected candidate will be instrumental in the deployment of new and enhanced equipment, facilities, and utilities, as well as the integration of cutting-edge technologies to support BioSpace's clinical and commercial product supply.
Key Responsibilities:
  • Offer technical guidance utilizing engineering principles and advance projects ranging from functional area initiatives aimed at enhancing process equipment/utilities/facilities to extensive capital projects that incorporate new drug product manufacturing and device assembly and packaging technologies into clinical/commercial settings. Utilize engineering knowledge within the organization and industry best practices, ensuring adherence to relevant environmental health and safety regulations, while aligning with evolving regulatory standards and internal quality benchmarks to facilitate new equipment and/or modifications to existing equipment/utilities/facilities.
  • Lead Commissioning & Qualification (C&Q) initiatives for project teams to propel C&Q efforts for smaller projects (up to $3M) that encompass facility construction and the integration of new equipment into clinical/commercial environments. This includes fostering effective communication among cross-functional teams (e.g., Facilities & Engineering, Manufacturing, Quality, Project Controls, Project Management, EHSS) and functional management, overseeing contractor selection for C&Q execution, managing their training and performance, C&Q deliverables, and timelines to ensure project objectives are met, while maintaining compliance with BioSpace's safety, C&Q, and Quality standards.
  • Oversee the portfolio of enhancement/innovation projects within the Facilities & Engineering drug product engineering group, employing strategic methodologies and resource prioritization.
  • Possess comprehensive knowledge of compliance and regulatory requirements for equipment validation, operation, and maintenance, and support regulatory inspections and audits.
  • Be prepared for up to 10% domestic/international travel.
Candidate Expectations

We recognize that each individual brings unique strengths to our mission of serving patients. The ideal candidate will possess the following qualifications:
Basic Qualifications:
Doctorate degree
Or
Master's degree with 2 years of Engineering and/or Operations experience
Or
Bachelor's degree with 4 years of Engineering and/or Operations experience
Or
Associate's degree with 8 years of Engineering and/or Operations experience
Or
High school diploma/GED with 10 years of Engineering and/or Operations experience
Preferred Qualifications:
  • Master's degree in Chemical or Mechanical Engineering.
  • 6+ years of relevant professional experience, including 3+ years in a Biopharmaceutical operations/manufacturing setting.
  • Experience in a regulated environment (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation.
  • Direct experience with design and troubleshooting of GMP Biopharmaceutical Production facility equipment/systems, including continuous fill lines, lyophilization, inspection, device assembly, and chromatography.
  • Ability to analyze challenges and propose engineering solutions based on data-driven methodologies (e.g., Root Cause Analysis, Statistical Process Control, Six Sigma, Predictive Maintenance).
  • Experience applying engineering principles to the design and execution of system modifications and capital projects.
  • Understanding of the capital project execution process in a GMP Biopharmaceutical Production facility, including procurement, construction, startup, and validation.
  • Knowledge of safety protocols in a GMP Biopharmaceutical Production environment.
  • Self-motivated, organized, and capable of managing multiple tasks in project settings, with strong communication and collaboration skills.
  • A team-oriented individual who thrives in a collaborative culture.
  • Excellent leadership, technical writing, and communication/presentation abilities.
What We Offer

At BioSpace, Inc., we prioritize the professional and personal growth of our team members while striving to develop treatments that benefit others.

We provide a comprehensive Total Rewards Plan that includes health and welfare benefits for employees and eligible dependents, financial plans for retirement savings, work/life balance initiatives, and career development opportunities, which encompass:
  • A robust employee benefits package, featuring a Retirement and Savings Plan with substantial company contributions, medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program.
  • Stock-based long-term incentives.
  • Award-winning time-off policies and company-wide shutdowns.
  • Flexible work arrangements, including remote work options where feasible.
Join Us

Embark on a career that challenges the ordinary. We look forward to your application.