Job Description/Summary

The appropriately experienced professional possesses practical and specialized knowledge in industrial hygiene and its application within a biologics manufacturing environment. In this role, you will integrate EHS expertise directly into biomanufacturing technology transfer initiatives, acting as the dedicated single point of contact to ensure that safety is embedded into all transfer activities and business processes.

Job Duties/Responsibilities

● Proactively identify, assess, and mitigate potential Safety, Health, and Environmental risks associated with the transfer of new or changed products, services, processes, and equipment.

● Participate in preliminary hazard identification and initial risk screening during the sourcing phase to identify "no-go" hazards.

● Conduct gap analyses and risk assessments to determine the scope of process evaluations for technical transfers.

● Recommend, design, and implement engineering controls and other measures to mitigate hazards identified during tech transfer assessments.

● Develop and deliver specialized training for workers and managers on hazard awareness, controls, and novel procedures associated with transferred processes.

● Review and approve chemical bills of materials (BOMs), equipment documentation, and process modifications to identify specific handling controls.

● Issue and track Category 1 (Pre-start) and Category 2 (Post-start) CAPAs to ensure compliance with safety controls.

● Ensure site compliance with occupational health and safety regulations and act as the primary resource on regulatory changes

Mandatory Skills Required

● In-depth conceptual and practical knowledge in Occupational Health and/or Industrial Hygiene, including relevant regulations, codes, and consensus standards (OSHA, Cal/OSHA, DOT, NIOSH, ACGIH)

● Proven ability to evaluate complex chemical processes to identify/mitigate hazards.

● Hands-on experience in risk assessment, exposure monitoring, and development of control solutions (engineering, administrative, PPE)

● Problem-solving ability and sound judgment based on analysis of multiple sources of information

Nice to Have Skills

● Previous experience in manufacturing and/or the biotechnology/pharmaceutical industry with technology transfer projects

● Basic knowledge of core safety and Environmental regulations applicable to GMP and non-GMP biologics manufacturing environments

● Experience with Management of Change (MOC) processes and documentation systems.

● Familiarity with Pre-Start-Up Safety Review (PSSR) procedures

Qualifications/Experience Required

● Bachelor's Degree from an accredited 4-year college or university with a major in Chemistry, Life Science, Engineering, Occupational Safety, or other relevant scientific field

● Must be proficient in recommending and validating engineering controls (e.g., glove boxes, fume hoods).

● Demonstrated ability to work independently within broad guidelines and policies

● Self-starter with excellent communication skills and ability to influence safety culture across all levels of the organization

● Ability to walk, stand, and climb in industrial environments for extended periods

● Ability to wear required personal protective equipment (PPE)

● Ability to lift and carry up to 25 pounds occasionally

Top Primary Goals for New Hire within 60 Days

● Get onboarded into the active biomanufacturing technology transfer project(s) and establish yourself as the SHE single point of contact for the transfer team.

● Lead and complete your first comprehensive SHE assessment covering preliminary hazard identification, chemical BOMs, equipment evaluation, and facility compatibility

● Develop and issue your first set of Management of Change (MoC) records and CAPAs to establish safety controls and procedural documentation for novel processes or chemicals.

Pharmaceutical Company

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Senior Industrial Hygienist