The Sr. Associate, Manufacturing Systems provides technical engineering support for automation, equipment optimization, system upgrades, replacements, and modifications within a regulated manufacturing environment. This role ensures that maintenance operations, documentation, and system performance comply with corporate policies, industry standards, regulatory requirements, and FDA expectations. The specialist supports cross‑functional teams, leads troubleshooting efforts, and contributes to continuous improvement initiatives across manufacturing systems.
RESPONSIBILITIES
- Evaluate utility systems, process maintenance activities, instrumentation, calibration, electrical systems, and technical cleaning systems to ensure compliance with industry, regulatory, and FDA standards.
- Ensure maintenance team training programs, SOPs, and operational standards are consistent and properly implemented.
- Provide technical support to the maintenance team on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process maintenance issues.
- Assist the maintenance team during FDA and other regulatory inspections; support responses to regulatory inquiries.
- Support investigations related to high‑purity water systems and environmental monitoring alert/action notifications.
- Assist in developing and maintaining an audit program for maintenance operations.
- Facilitate routine audits of documentation, activities, and operations to ensure a continued state of compliance.
- Support plant engineering in evaluating and implementing engineering improvements, policy updates, compliance enhancements, and optimization programs.
- Assist with testing proposed sanitization and maintenance procedure changes for process, utility, and clean room systems.
Additional responsibilities may be assigned.
SKILLS
- Strong understanding of validation protocol requirements
- Equipment‑specific technical expertise
- Analytical problem‑solving skills
- Project management and planning
- Scheduling and coordination
- Computer literacy and familiarity with automation systems
- Leadership and team‑building
- Strong verbal communication
- Technical writing and documentation
- Facilitation and cross‑functional collaboration
- Ability to manage change effectively
- Strong organizational skills and ability to follow assignments through completion
- Ability to support compliance investigations and regulatory expectations
- Ability to work independently and interact effectively across multiple levels
Requirements
- Master’s degree OR
- Bachelor’s degree + 2 years of engineering experience OR
- Associate’s degree + 6 years of engineering experience OR
- High School Diploma/GED + 8 years of engineering experience
PREFERRED QUALIFICATIONS (Standout Attributes)
- Experience with recipe entry in packaging equipment
- Automation assessment experience to determine correct recipe parameters
- Experience with Systech systems
- Strong understanding of decision‑making techniques
- Risk management experience
Benefits
- 6-month contract with possible extension
- Administrative shift
Skills Required
- Master's degree
- Bachelor's degree and 2 years of engineering experience
- Associate's degree and 6 years of engineering experience
- High school diploma or GED and 8 years of engineering experience
- Experience with recipe entry in packaging equipment
- Automation assessment experience determining correct recipe parameters
- Experience with Systech systems
- Strong understanding of decision-making techniques
- Risk management experience
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
