Planning and Preparation of Engineering Standard Operating Procedures, Risk Assessment’s.
Coordinate with cross functionality teams to initiate and close Change Controls, CAPA’s and deviations.
Assist maintenance team in implementation of new tools, systems, and technologies to drive operational efficiency.
Assist the engineering manager in preparing request for proposals for new equipment and projects
Assist the maintenance team to deploy software tools and techniques to enhance compliance
Assist the projects team in preparing cost estimates
Perform other duties as assigned.
Follow the laid down Quality Culture Principles and Behaviors
Qualifications - Skills & Requirements
Master's degree in Engineering or a related technical discipline.
Knowledge of GMP-regulated environments, qualification/validation practices, and quality systems is preferred.
Familiarity with engineering documentation, maintenance systems, and quality management software.
Strong analytical, organizational, and problem-solving skills.
Effective communication and collaboration skills with cross-functional teams.
Proficiency in Microsoft Office applications and engineering-related software tools.
Education & Experience
Bachelor's/Master's Degree in Engineering.
0-2 years of experience in cGMP related Engineering activities.
Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
Dental Benefits with three dental plan options through CIGNA
Vision Plan with two plan options through VSP
Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
Disability Insurance, Voluntary Short-Term Disability and State Disability
Long-Term Disability (LTD), State (short term) disability – where applicable
FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available
HSA (Health Savings Account)
401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
Critical Illness and Accidental Insurance
Legal and Identity Theft Insurance
Paid Time Off - Paid vacation, PTO, Holiday
Notice to Recruitment Agencies
Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.
Compensation
Min
- USD $26.00/Hr.
- Physical Requirements
FIELD - While performing the duties of this job the employee is required to: • Work in a temperature controlled office environment or travel via vehicle or commercial transportation • While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment • Position requires some degree of travel for business purposes • Employee may use computer, phone, copier and other office equipment in the course of a day • Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements
Job requires you to worker to reach or work above the shoulder
Blood/Fluid Exposure Risk
Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
Preparation, Review and Approval of Engineering Drawings.
Handling of quality management software.
Planning and execution of equipment and Utility IQ/OQ qualifications
Planning and Preparation of Engineering Standard Operating Procedures, Risk Assessment’s.
Coordinate with cross functionality teams to initiate and close Change Controls, CAPA’s and deviations.
Assist maintenance team in implementation of new tools, systems, and technologies to drive operational efficiency.
Assist the engineering manager in preparing request for proposals for new equipment and projects
Assist the maintenance team to deploy software tools and techniques to enhance compliance
Assist the projects team in preparing cost estimates
Perform other duties as assigned.
Follow the laid down Quality Culture Principles and Behaviors
Master's degree in Engineering or a related technical discipline.
Knowledge of GMP-regulated environments, qualification/validation practices, and quality systems is preferred.
Familiarity with engineering documentation, maintenance systems, and quality management software.
Strong analytical, organizational, and problem-solving skills.
Effective communication and collaboration skills with cross-functional teams.
Proficiency in Microsoft Office applications and engineering-related software tools.
