Technical Operations Contractor - II (Associate)

Reference #: 68226f4b-35e3-4197-b0ed-6281c06a97e9

Title- Technical Operations Contractor - II (Associate) Location- WestPoint, PA or Rahway, NJ Duration- 6 Months Shift- 9 am to 3pm (3days onsite)

**Description

Position Description** The Associate, Technical Operations within Global Clinical Supply (GCS) is responsible for managing aspects of equipment/facility project activities, and supporting infrastructure-related projects to establish, upgrade, and modernize Clinical Supply Operations (CSO) facilities. Specifically, this role will: Track Clinical Supply Operations (CSO) equipment globally. Support qualification, installation, and release of new equipment, and decommissioning of old equipment. Support recurring issues and deficiencies with equipment/facilities. Support process development (partner with business area) to enable equipment use. Collaborate on Preventative Maintenance plan development for new equipment/facilities. Support clients Permanent Inspection Readiness and Continuous Improvement expectations, and escalate inconsistency across sites for resolution Support significant cross-functional investigations involving CSO, and support larger or recurring investigations/CAPAs coming from routine issues

Position Qualifications:

Education Minimum Requirement: Associate degree in engineering, scientific, or related field. Preferred- Bachelor's degree in engineering, scientific, or related field.

Required Experience and Skills:

At least 5 years' experience in an engineering and/or operations role within the pharmaceutical industry. Experience with pharmaceutical packaging (primary packaging of solid dosage forms, secondary packaging of vaccines/biologics, medical devices). Strong compliance mindset, and understanding of cGMP, including FDA and EMEA. Ability to work effectively across boundaries to build strong collaborative relations with other groups. Excellent communication skills. Experience with change management, investigations, and root cause analysis

Preferred Experience and Skills:

Project management certification (e.g. PMP, CAPM). Experience with Operational Excellence methodology such as Six Sigma and Lean methods principles and tools. Experience with SAP or other production software.

SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at [email protected] if you require reasonable accommodation.