Senior Pharmaceutical Facilities Maintenance Specialist 2nd shift
3 days ago
Senior Pharmaceutical Facilities Specialist
2nd shift 1230pm -9pm
Job Summary:
Support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMP) and Good Documentation Practices (cGDP) requirements.
Area Of Responsibility:
- Develop and maintain electronic and paper records on pharmaceutical manufacturing equipment, utilities, and systems to maintain operations and validation
- Operate production equipment (Isolators filling line, Lyophilizer, powder filling) for setup and or production purposes as needed
- Manage execution of PMP programs consistent with cGMP engineering maintenance requirements
- Interact with and direct vendors for manufacturing improvement and plant maintenance (i.e. HVAC, Clean Utilities, trades) primary support for Security/System Monitoring/Fire System, janitorial services, and waste water certifications
- Perform non-routine and off-hours tasks as necessary
- Support area validation, calibration, certification efforts, and the transfer of new processes to the manufacturing area
- Perform equipment, utility, and plant validation as needed
- Review and update maintenance SOPs for plant, equipment, and utilities
- Follow all company policies related to job safety
- Work independently with minimal supervision using some standard procedures as well as troubleshooting and decision making
- Troubleshoot complex manufacturing equipment/plant/utility problems
- Support operations improvement and maintenance projects
- Perform improvements and maintenance as required to support all operations
- Support validation maintenance program
- Execute validations for manufacturing equipment and processes as needed
- Maintain and review records for operations plant, equipment, and utilities
- Monitor steam utility per MA State requirements
- Maintain records for waste water requirements
- Manage janitorial services and plant waste stream
- Support in the development and mentor of peers
- Monitor process operations to ensure compliance with specification
- Ensure equipment operational readiness
- Subject matter expert for multiple processing technologies (vacuum pumps, chilled water systems, autoclaves, WFI, Clean Steam)
- Other duties as assigned
Travel Estimate:
Up to 5%
Education and Job Qualification:
- High school diploma or equivalent required
- Technical certification preferred
- Knowledge of pharmaceutical Plant/Maintenance/manufacturing Operations or related environment
- Knowledge of aseptic techniques
- Ability to read & create engineering drawings
- State boilers "Special License to Operate” or higher preferred / obtain within 6 months of employment
- Electrician's license preferred
- Ability to plan, prioritize and organize diversified workload
- Familiarity with use of computers and MS Office
Experience
- Minimum 2-5 years related experience
- Experience working with process equipment (compounding, vial washing, vial filling, ampoule and powder filling)
- Experience working with electronic document systems ( CMMS work orders ,LMS, Track Wise, Master Control ) or similar systems
- Experience with Building Automation Systems
- HAZMAT training
- Formal cGMP training
- Proficient with use of hand tools and power equipment
- WFI water system experiences a plus
-
Billerica, United States Kaztronix LLC Full timeSenior Pharmaceutical Facilities Specialist 2nd shift 1230pm -9pmJob Summary:Support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMP) and Good Documentation Practices (cGDP) requirements.Area Of Responsibility:Develop and...
-
Billerica, Massachusetts, United States Kaztronix LLC Full time{"Job Title": "Senior Pharmaceutical Facilities Maintenance Specialist", "Job Summary": "At Kaztronix LLC, we are seeking a highly skilled Senior Pharmaceutical Facilities Maintenance Specialist to join our team. As a key member of our maintenance team, you will be responsible for ensuring the smooth operation of our pharmaceutical manufacturing plant,...
-
Plant Services Specialist
1 month ago
Billerica, United States Sun Pharmaceutical Industries, Inc. Full timeThis is a 2nd shift postion, with an additional 10% shift differential for all 2nd shift hours worked Job SummarySupport pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements. Area Of Responsibility Develop and...
-
Plant Services Specialist
1 month ago
BILLERICA, United States Sun Pharmaceutical Industries, Inc. Full timeThis is a 2nd shift postion, with an additional 10% shift differential for all 2nd shift hours worked Job SummarySupport pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements. Area Of Responsibility Develop and...
-
Plant Services Specialist
1 month ago
Billerica, MA, United States Sun Pharmaceutical Industries, Inc. Full timeThis is a 2nd shift postion, with an additional 10% shift differential for all 2nd shift hours worked Job Summary Support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements. Area Of Responsibility Develop and...
-
Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full timeJob SummaryAs a Pharmaceutical Formulation and Dispensing Specialist at Sun Pharmaceutical Industries, Inc., you will play a critical role in the formulation and dispensing of pharmaceutical products in a clean room environment. This position requires attention to detail, strong organizational skills, and the ability to work in a fast-paced environment.Key...
-
Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full timeJob SummaryAs a Pharmaceutical Formulation and Dispensing Specialist at Sun Pharmaceutical Industries, Inc., you will play a critical role in the formulation and dispensing of pharmaceutical products in a clean room environment. This position requires attention to detail, strong organizational skills, and the ability to work in a fast-paced environment.Key...
-
Plant Services Specialist
1 month ago
Billerica, MA, United States Sun Pharmaceutical Industries, Inc. Full timeThis is a 2nd shift postion, with an additional 10% shift differential for all 2nd shift hours worked Job SummarySupport pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements. Area Of Responsibility Develop and...
-
Plant Services Specialist
4 weeks ago
Billerica, United States Sun Pharmaceutical Industries Full timeThis is a 2nd shift postion, with an additional 10% shift differential for all 2nd shift hours workedJob SummarySupport pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements.Area Of Responsibility Develop and...
-
Plant Services Specialist
4 weeks ago
Billerica, United States Sun Pharmaceutical Industries Full timeThis is a 2nd shift postion, with an additional 10% shift differential for all 2nd shift hours worked Job Summary Support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements. Area Of Responsibility Develop and...
-
Formulation and Fill Technician II
2 weeks ago
Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full timeJob Summary:Sun Pharmaceutical Industries, Inc. is seeking a highly skilled Formulation and Fill Technician II to join our team in a clean room environment. As a key member of our manufacturing team, you will be responsible for formulating and dispensing pharmaceutical products according to current Good Manufacturing Practices (cGMPs) and utilizing Standard...
-
Plant Services Specialist
4 weeks ago
Billerica, United States Sun Pharma Full timeThis is a 2nd shift position with an additional 10% shift differential. Job Summary Support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements. Area Of Responsibility Develop and maintain records on...
-
Pharmaceutical Formulation Technician I
4 weeks ago
Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full timePosition Overview:This role is designated for the second shift and includes a 10% shift differential.Job Responsibilities:As a Formulation Technician, you will be responsible for the precise formulation and dispensing of pharmaceutical products, adhering to current Good Manufacturing Practices (cGMPs) and following established Standard Operating Procedures...
-
Plant Services Specialist
4 weeks ago
Billerica, United States Sun Pharma Full timeThis is a 2nd shift position with an additional 10% shift differential. Job Summary Support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements. Area Of Responsibility Develop and maintain records on...
-
Plant Services Specialist
4 weeks ago
billerica, United States SUN PHARMA Full timeThis is a 2nd shift position with an additional 10% shift differential.Job SummarySupport pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements.Area Of ResponsibilityDevelop and maintain records on pharmaceutical...
-
Plant Services Specialist
1 month ago
Billerica, United States SUN PHARMA Full timeThis is a 2nd shift position with an additional 10% shift differential.Job SummarySupport pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements.Area Of ResponsibilityDevelop and maintain records on pharmaceutical...
-
Pharmaceutical Formulation Technician I
4 weeks ago
Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full timePosition Overview:This role operates on a second shift and includes a 10% shift differential.Job Responsibilities:As a Formulation and Fill Technician I, you will be responsible for the preparation and dispensing of pharmaceutical products in compliance with current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs)...
-
Pharmaceutical Manufacturing Specialist II
4 weeks ago
North Billerica, United States Randstad Full timeJob OverviewPosition: Manufacturing Technician II (2nd Shift)Location: Billerica, MAShift: 4:00 PM - 2:30 AM, Monday to ThursdayCompensation: $30/hrContract Type: Temporary to PermanentRole SummaryWe are looking for a committed Manufacturing Technician II to contribute to our operations in Billerica, MA. This position entails the operation and upkeep of...
-
Plant Operations Specialist
3 weeks ago
Billerica, Massachusetts, United States SUN PHARMA Full timeJob SummaryThis is a 2nd shift position with an additional 10% shift differential.Key Responsibilities:Develop and maintain records on pharmaceutical manufacturing equipment, utilities, and systems to maintain operations and validationManage execution of Preventive Maintenance Programs (PMPs) consistent with current Good Manufacturing Practices (cGMPs)...
-
Senior Associate, Compliance Specialist
2 weeks ago
Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full timeJob SummaryThe Senior Associate, Compliance Specialist provides scientific support in the root cause analysis and closure of Out-of-Specification (OOS) investigations, Out-of-Trend (OOT) investigations, and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Management...