CDMO, CMO, Contract Development and Manufacturing Organisation

Process Safety Management Associate

Job Title
Process Safety Management Associate
Location
Germantown,  WI 53022
Other Location
Description

Summary of Role
 
 The Process Safety Management Associate is accountable for driving results in a fast-paced environment by being responsible for the development, implementation and sustainment of the site Process Safety Management (PSM) and EHS programs to ensure the safety of all employees, visitors and contractors, protect the environment, and maintain compliance with all Federal, State and local regulations.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Determines methods and procedures on new assignments and may provide guidance to other personnel.  The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile.  

Essential Functions

  • Coordinates the implementation of the OSHA Process Safety Management (PSM) program.
  • Prepares and organizes written presentations, documentation and reports pertaining to process safety activities.
  • Identifies process safety improvement opportunities through interaction with all process safety stakeholders.
  • Makes recommendations and justifies new tools and work process improvements.
  • Ensures that process safety-related Standard Operating Procedures (SOPs), engineering standards and guidelines are developed, reviewed and updated as needed.
  • Participates in Process Hazard Analyses (PHAs) and maintains the qualifications of a PHA facilitator.
  • Reviews PHAs to ensure consistency with company policy and tracks recommendations.
  • Participates in key incident investigations and maintains the qualifications of a Root Cause Analysis (RCA) facilitator.
  • Participates in key Pre-Startup Safety Reviews (PSSR).
  • Participates in process safety audits / assessments.
  • Develops and delivers process safety training.
  • Supports the Management of Change (MOC) process by ensuring that management systems are in place and effective.
  • Works closely with project managers on capital and business projects.
  • Prepares and submits reports on a timely basis to appropriate agencies.
  • May serves as the liaison with Federal, State and local regulatory agencies.
  • May interact with customers during site EHS reviews and audits.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Education and Experience

  • Bachelor’s degree in engineering or related discipline with minimum 5 years of experience in a PSM covered facility (preferably pharmaceutical or chemical manufacturing environment) and prior experience facilitating PHA studies is required.
  • Certification as a PHA facilitator or other EHS related discipline preferred.
  • This position is not eligible for a flexible schedule.
  • This position is not eligible for remote / hybrid work location.

Key Competencies

  • Knowledge of PSM through working in a manufacturing environment as a PSM Engineer or equivalent role with direct responsibility for implementation of various aspects of PSM program.
  • Participation as a member in at least five separate PHAs, understanding of Layers of protection Analysis (LOPA), and familiarity with PHA software such ‘PHA Pro’ or ‘PHA works’.
  • Ability to develop new training materials, programs and tools to analyze and improve training effectiveness
  • Ability to lead investigation of incidents, near misses and property damage incidents and ensure follow-up is completed to minimize future exposure: document same.
  • Ability to perform regular audits on EH&S programs and revise as necessary to comply with federal, state, local requirements, and company environmental, health, and safety policies, procedures and practices.
  • Ability to lead safety hazard evaluations and risk assessments on facility operations and equipment.
  • Ability to foster, maintain and improve safety culture through engagement of stakeholders in implementation of EHS programs and policies.
  • Candidates need to be competent with IT systems, and Microsoft Office including Outlook, Word and Excel.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. 
  • Duties, responsibilities, and activities may change at any time with or without notice. 
Why Consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 

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