From BioPharma Consulting JAD Group's posting. “We” and “our” refer to the employer.
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
About this listing
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
