Confidential
Director of Operations at MercVen Healthcare | Director of Recruitment at MercVen Staffing
We are seeking an experienced
Manufacturing Specialist
to support
Metered Dose Inhaler (MDI) production operations
at our Fall River, MA facility. This role involves overseeing packaging processes, ensuring compliance with
cGMP
and
FDA
standards, and supporting continuous improvement initiatives within a fast-paced, regulated manufacturing environment. The Manufacturing Specialist will coordinate daily production activities, monitor efficiency and quality, and collaborate with cross-functional teams to maintain operational excellence. Key Responsibilities
Coordinate and oversee daily production and packaging activities to meet schedules. Ensure compliance with
cGMP ,
FDA regulations , and internal quality standards. Maintain and review documentation, including batch records, logs, and deviation reports. Assist in investigations related to
deviations, non-conformances, and CAPAs . Collaborate with QA, Engineering, Supply Chain, and R&D teams to troubleshoot issues. Support the implementation of process improvements and new technologies. Track operational metrics and performance data to identify efficiency opportunities. Create and manage
purchase requisitions (PRs)
in SAP for equipment, consumables, and services. Maintain strong communication with internal teams and external suppliers/vendors. Promote and enforce
safety protocols and Good Packaging Practices (GPPs) . Qualifications
Bachelor’s degree
in Pharmaceutical Sciences, Mechanical, Electrical, or Production Engineering (or related field). 5–11 years
of experience in manufacturing, packaging, or operations (pharmaceutical preferred). Experience in
pharmaceutical MDI packaging
is a plus. Strong knowledge of
cGMP
and
FDA regulations . Experience with
SAP
and data analysis tools. Excellent
communication ,
problem-solving , and
teamwork
skills. Strong attention to detail and ability to thrive in a high-volume, regulated environment. 1st Shift:
07:00 AM – 03:30 PM 2nd Shift:
03:00 PM – 11:30 PM Shift assignment will depend on business needs and candidate preference. Salary & Benefits
Pay Range:
(based on experience and shift) 401(k) with company match Health, dental, and vision insurance Health Savings Account (HSA) & Flexible Spending Account (FSA) Paid Time Off (vacation, sick, flex days, and holidays) Short-term and long-term disability coverage Parental leave and employee discounts Physical Requirements
Ability to stand or walk for long periods. Must be able to lift up to 50 lbs as needed. PPE use and adherence to safety protocols required.
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We are seeking an experienced
Manufacturing Specialist
to support
Metered Dose Inhaler (MDI) production operations
at our Fall River, MA facility. This role involves overseeing packaging processes, ensuring compliance with
cGMP
and
FDA
standards, and supporting continuous improvement initiatives within a fast-paced, regulated manufacturing environment. The Manufacturing Specialist will coordinate daily production activities, monitor efficiency and quality, and collaborate with cross-functional teams to maintain operational excellence. Key Responsibilities
Coordinate and oversee daily production and packaging activities to meet schedules. Ensure compliance with
cGMP ,
FDA regulations , and internal quality standards. Maintain and review documentation, including batch records, logs, and deviation reports. Assist in investigations related to
deviations, non-conformances, and CAPAs . Collaborate with QA, Engineering, Supply Chain, and R&D teams to troubleshoot issues. Support the implementation of process improvements and new technologies. Track operational metrics and performance data to identify efficiency opportunities. Create and manage
purchase requisitions (PRs)
in SAP for equipment, consumables, and services. Maintain strong communication with internal teams and external suppliers/vendors. Promote and enforce
safety protocols and Good Packaging Practices (GPPs) . Qualifications
Bachelor’s degree
in Pharmaceutical Sciences, Mechanical, Electrical, or Production Engineering (or related field). 5–11 years
of experience in manufacturing, packaging, or operations (pharmaceutical preferred). Experience in
pharmaceutical MDI packaging
is a plus. Strong knowledge of
cGMP
and
FDA regulations . Experience with
SAP
and data analysis tools. Excellent
communication ,
problem-solving , and
teamwork
skills. Strong attention to detail and ability to thrive in a high-volume, regulated environment. 1st Shift:
07:00 AM – 03:30 PM 2nd Shift:
03:00 PM – 11:30 PM Shift assignment will depend on business needs and candidate preference. Salary & Benefits
Pay Range:
(based on experience and shift) 401(k) with company match Health, dental, and vision insurance Health Savings Account (HSA) & Flexible Spending Account (FSA) Paid Time Off (vacation, sick, flex days, and holidays) Short-term and long-term disability coverage Parental leave and employee discounts Physical Requirements
Ability to stand or walk for long periods. Must be able to lift up to 50 lbs as needed. PPE use and adherence to safety protocols required.
#J-18808-Ljbffr