Engineering Specialist - Deviation Writer

Location: Onsite in Morris Plains, NJ | Salary: $42 - $52 per hour (Based on Skills & Experience)

Elevate Your Career in Pharma Manufacturing – Become a Key Player at PDS Tech Commercial!

At PDS Tech Commercial, we’re seeking a talented Engineering Specialist - Deviation Writer to make a meaningful impact on our client's pharmaceutical manufacturing operations. If you’re driven by the opportunity to solve complex problems, ensure compliance, and help shape quality processes, this is your chance to join a dynamic team that’s transforming the industry.

Role Overview:

In this pivotal role, you'll be responsible for initiating, investigating, and managing deviations related to facilities and engineering processes. Your work will ensure that our operations meet the highest standards, directly contributing to operational efficiency and regulatory compliance. You’ll collaborate with cross-functional teams, author investigations, and design effective Corrective and Preventive Actions (CAPAs) to address and prevent deviations.

Key Responsibilities:

Deviation Management: Initiate, track, and resolve deviations related to facilities and equipment, meeting strict timelines.

Root Cause Analysis: Investigate and identify the root causes of issues, applying tools and expertise to find long-term solutions.

CAPA Development: Collaborate on the design and implementation of CAPAs to prevent recurrence and ensure ongoing process improvement.

Cross-Functional Collaboration: Work with teams to assess deviation impact, manage escalations, and deliver clear, timely reports.

Audit Support: Assist with internal and external audits to ensure regulatory compliance and adherence to industry standards.

What We’re Looking For:

Required Qualifications:

Education: BSc in Engineering or related scientific field.

Experience: 3+ years in GMP manufacturing, with at least 1 year in deviation/root cause analysis.

Skills: Strong knowledge of equipment/facility processes, CAPA development, and deviation management. Fluent in English (written and spoken).

Preferred Qualifications:

Experience in pharmaceutical manufacturing or related industries.

Familiarity with audits and health authority inspections.

Ready to take the next step? Apply today and be part of our success!

Pay Details: $42.00 to $52.00 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 ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance