Job Title: Manufacturing Systems Engineer - II (Associate)
Location: West Point, PA 19486
Duration: 8 Months

Summary:

We are seeking a detail-oriented professional with experience in computer system validation and GMP-regulated environments to support periodic reviews of laboratory and manufacturing systems. This role involves cross-functional collaboration, technical documentation review, and on-site system inspections.

---

Key Responsibilities:

• Collaborate with cross-functional teams across the West Point site to support system compliance activities.
• Perform periodic reviews of laboratory systems and manufacturing equipment.
• Manage periodic review schedules and generate detailed compliance reports.
• Review and verify system procedures, including backups and security protocols.
• Evaluate SDLC documentation to ensure alignment with internal and regulatory requirements.
• Assess system events, logs, and issues to ensure optimal performance and compliance.
• Review calibration and maintenance records for accuracy and completeness.
• Evaluate completed change control records for compliance.
• Analyze collected data and prepare comprehensive reports outlining findings and conclusions.
• Support implementation of computerized maintenance systems through data review and evaluation.

---

Must-Have Skills:

• Knowledge of computer system validation (CSV) processes

• Understanding of Software Development Life Cycle (SDLC)

• Experience in GMP / regulated environments (cGxP)

• Strong technical writing and documentation skills

• Solid computer proficiency

• Ability to work independently

---

Preferred Skills:

• Experience with Kneat (electronic validation system)

• Familiarity with lab systems and manufacturing equipment

• Leadership or facilitation experience

---

Education & Experience:

• Bachelor’s degree in Engineering or Science

• 2+ years of experience in the pharmaceutical or regulated industry

---

Work Environment:

• Onsite role – West Point

• Requires walking through labs, inspecting systems and equipment

• Interaction with lab owners and stakeholders across departments

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 45.00/hr.