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Manufacturing Operations Specialist | Morris Plains, NJ

Drive Excellence in Pharmaceutical Manufacturing & Ensure Quality Every Step of the Way

**Pay:** $27.26/hr (1st Shift) | $30.00/hr (2nd Shift)

Schedule:

+ Sunday – Thursday (6:00 AM – 2:30 PM / 1:00 PM – 9:30 PM)

+ Tuesday – Saturday (6:00 AM – 2:30 PM / 1:00 PM – 9:30 PM)

About the Role

PDS Tech Commercial, in partnership with a **leader in the pharmaceutical manufacturing industry** , is seeking a **Manufacturing Operations Specialist** to join the team in **Morris Plains, NJ** . This role is essential for maintaining operational efficiency, ensuring compliance with cGMP regulations, and supporting core manufacturing functions. From managing kitting and material flow to overseeing inventory accuracy and ISO8 operations, you’ll ensure the seamless production of life-changing pharmaceutical products.

Key Responsibilities

+ **Operational Compliance:** Adhere to all SOPs, work procedures, and batch records with a focus on **Right First-Time performance** . Ensure accurate **SAP/MES inventories** are maintained.

+ **Audit Readiness:** Maintain manufacturing support areas in an **“audit ready” state** .

+ **Equipment & Safety:** Ensure equipment cleaning and maintenance are performed per SOPs; escalate compliance or safety issues and support event reconciliation.

+ **Systems Proficiency:** Utilize **LIMS, SAP, MES** , and other operating systems for material management and reporting.

+ **Inventory & Material Management:** Support **cycle counts** , receiving, storage, processing of materials, and **LN2 storage accuracy** .

+ **Dispensary / ISO8 Activities:**

+ Maintain proper **status segregation and storage** of conditioned and ambient materials.

+ Monitor **Kanban system** , ensure **FEFO/FIFO compliance** , and stage kits for production.

+ Monitor staged kits for expiration and ensure proper utilization.

+ Maintain adequate **gowning materials** and **non-BOM supplies** in ISO8 areas.

Required Qualifications

+ 1–3 years of experience in a **cGMP/FDA-regulated environment** .

+ High School diploma required; **Bachelor’s degree preferred** .

+ Strong **interpersonal, written, and communication skills** .

+ Excellent **organizational, problem-solving, and follow-up skills** ; ability to work independently.

+ Ability to lift up to **50 lbs. (assisted)** .

+ Experience handling **chemicals, corrosives, solvents, or bio-hazardous materials** .

Preferred Qualifications

+ Experience with **manufacturing support operations** in ISO8 or dispensary areas.

+ Familiarity with **inventory control systems** and **kitting processes** .

+ Prior exposure to **GMP compliance audits** and pharmaceutical production standards.

Why Join Us

At **PDS Tech Commercial** , we empower our employees to make a meaningful impact in pharmaceutical manufacturing. When you join our team, you will:

+ Work with a **leading company in the pharmaceutical industry** and contribute to the production of vital medicines.

+ Gain exposure to **advanced manufacturing systems** and cGMP processes.

+ Be part of a culture that values **precision, accountability, and continuous improvement** .

+ Receive **competitive pay** and a supportive work environment focused on **growth and professional development** .

Take the Next Step

If you’re detail-oriented, safety-conscious, and passionate about operational excellence in pharmaceutical manufacturing, we want to hear from you.

**Apply today** to join the PDS Tech Commercial team in **Morris Plains, NJ** , and help ensure quality and compliance every step of the way.

**Pay Details:** $27.26 to $30.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.pdstech.com/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

+ The California Fair Chance Act

+ Los Angeles City Fair Chance Ordinance

+ Los Angeles County Fair Chance Ordinance for Employers

+ San Francisco Fair Chance Ordinance

**Massachusetts Candidates Only:** It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.