Technical Operations Engineer (Pharmaceutical)

Technical Operations Engineer (Pharmaceutical) - Monday through Friday, 8am-4:30pm, fully in office/no remote work.

This position is responsible for understanding, investigating, authors, and managing the effectiveness of maintenance and production-based deviations/CAPAS. The position will review industry standards/developments, evaluate the potential impact. Develop strategies and measurable goals for improvements, and manage change if impact is apparent. The position will focus on working with other Company departments to identify opportunities for improvements to operations, working with other departments in a constructive manner to ensure proper implementation. The position will review facility system trends, assess impact on operations and provide corrective measures. The position will examine operational metric data for negative trends and investigate to assign cause and provide corrective action suggestions. The position is also responsible to author SOPs and SOP revisions, as well as training programs. 

Responsibilities:

• Understands, investigates, authors, and manages the effectiveness of maintenance and production-based deviations/CAPAS.
•  Acts as a liaison with Company departments to identify opportunities for improvements. Develops strategies and measurable goals for improvements, and takes lead in implementing strategies in a constructive manner with departments.
• Reviews, evaluates, and provides feedback on production/metric data in order to develop continuous improvement strategies. Reviews equipment and processes challenging the current conditions for improvements, working with other departments to implement agreed upon improvements.
• Authors SOPs and SOP revisions, and training programs, acting as a technical writer. Supports the creation of validation protocols.
• Systematically performs assessment of operational risks as well as project risks with potential operational impact, plus the definition, documentation, and monitoring of mitigation plans.
• Provides project leadership as assigned or directed, producing high quality project plans on timelines, documenting costs and resources, integrating risk management, developing and communicating appropriate strategies for project implementation e.g. develops and creates integrated detailed operational project plans, analyzes and monitors the project timelines, impact of risks, resources and costs (investments).
• Analyzes new processes and equipment with the intent of achieving continuous improvement of present methods. Facilitates, educates and partners with production management and colleagues to lead a culture of continuous improvement efforts.
•  Makes recommendations to management on equipment/systems/process performance and design improvements.
• Assists in interacting with regulatory officials to convey the compliance level of the facilities and equipment quality system during regulatory inspections. 
• Assists in providing technical support for deviations.
• Assists in providing training to appropriate personnel related to equipment systems. 
• Assists in providing engineering support to the Company activities. 
• Assists in preparing the Company for participation in and oversight of on-site regulatory, customer and third-party audits.
• Stays current with regulatory guidance. Informs leadership team and internal groups of changes and Company impact.
• Promote a safe and harmonious work environment. 
• Maintain compliance with SOPs, GMPs, and all company policies.
• Other duties as assigned or required. 

• A Bachelor’s degree from a regionally accredited institution in Engineering or Technical Science 
• Minimum 5 years engineering experience in pharmaceutical or other highly regulated industry
• Knowledge of general computer functions such as Microsoft Office programs, spreadsheets, etc. 
• Knowledge in commissioning, qualification and validation practices
• Knowledge and understanding of processes relevant to validations and compliance of the manufacturing and production of regulated products, regulatory and development processes, how regulatory entities approach inspections, responding to regulatory observations, regulatory cGMP requirements for pharmaceuticals, regulatory approval processes, cGMPs and SOPs, regulatory entity inspections requirements, regulatory guidance documents
• Knowledge and skill in audit schemes
• Knowledge in the process of change control activities
• Skill in handling several projects or tasks at the same time, or within a given time frame 
• Advanced Problem Safety Sensitivity; the ability to recognize a safety issue or potential safety issue 
• Skill to use time management techniques in personal daily tasks and that of others 
• Skill in quality and compliance vigilance 
• Ability to inspect the work of others and coach performance in line with company standard operating procedures
• Ability to apply critical thinking 
• Advanced interpersonal and communication skills
• Ability to develop process control systems, including the ability to write policies and work instructions
• Ability to effectively articulate and present the company’s quality strategy to our employees, senior management, regulatory bodies and customers.
• Ability to be flexible in work hours 
• Ability to provide motivational support 
• Ability to maintain a professional, positive attitude at all times 
• Advanced project management and documentation skills 
• Ability to use training/instructional methods and procedures appropriate for the situation and audience 
• Ability to instruct/teach one on one on how to perform functions 
• Ability to trust, develop, maintain, and strengthen partnerships with others inside the organization who can provide information, assistance, and support 
• Ability to lead by example 
• Ability to communicate with coworkers, management team members, and other individuals in a courteous and professional manner 
• Ability to work in a fast paced environment 
• Ability to pay close attention to detail and coordinate various activities simultaneously 
• Ability to complete assigned tasks

Physical Components:

• Seeing: Must be able to read reports and use computer 75-100% of time
• Hearing: Must be able to hear well enough to communicate with coworkers 75-100% of time
• Standing/Walking/Mobility: Must be able to stand to open files and operate office equipment; mobility between departments and attend meetings of coworkers and management 75-100% of time
• Climbing/Stooping/Kneeling: Must be able to climb, stoop, or kneel to perform routine tasks within the scope of job 50-74% of time
• Lifting up to 40 lbs./ Pulling/Pushing within the scope of job 25-49% of time 
• Touching/Grasping/Feeling: Must be able to write, type, and use office equipment; along with handling material and equipment 75-100% of time

About Us: https://www.steri-pharma.com

Notice of Employee Rights, Protections, and Obligations under Labor Law Section 740: https://dol.ny.gov/system/files/documents/2022/02/ls740_1.pdf

EEOC 'Know Your Rights' Poster: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

Employee Rights Under the Polygraph Protection Act: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf