Asset Lifecycle Lead

Onsite: Morris Plains, NJ

Start: ASAP

Contract Length: 12 months to start, possible to extend

Department: Engineering

Reports to (Job Title): Director Engineering

Pay range: $50.00 - $67.00 per hour (depending on experience)

Job Purpose:

Responsible for the management of the Asset Lifecycle Program for all equipment, systems, facilities and utilities at the Morris Plains site from procurement through decommissioning.

Major Accountabilities:

o Manage the Asset Lifecycle Program for all equipment, systems, facilities and utilities from procurement through decommissioning, including the following main functions:

• Serve as the primary subject matter expert for the Asset Lifecyle Program.

• Utilize Computerized Maintenance Management System (CMMS) to manage the following aspects of the Asset Lifecycle program:

Enrollment/Installation

Initial Entry into Service

Removal & Return to Service

Changes/modifications to assets, including relocation, repairs and parts replacement

Scheduled events (e.g. calibration, preventative maintenance) and related Work Plan Templates, Measurement Data Templates and Sensor Risk Assessments

Work requests/work orders, including processing, generation, tracking and follow-up; ensure work order completion, review, approval and close-out.

Decommissioning

• Manage Master Data for equipment object management in Manufacturing Execution System (MES)

• Manage Standard Operating Procedures (SOPs), Work Procedures (WPs) and Forms related to Asset Lifecycle (e.g., equipment operation, calibration and preventative maintenance) including revisions and periodic reviews.

Key Performance Indicators:

o On-time project completion

o Engineering KPIs

o Change Control KPIs

o Customer satisfaction

o Avoidance of critical observations during internal/external inspections

Ideal Background:

Education:

o BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.

Languages: Fluent in speaking / writing in English

Experience:

o Experienced in a GMP regulated environment (pharmaceutical preferable).

o Minimum 5 years of asset lifecycle experience.

o Experience with manufacturing and laboratory equipment and change controls.

o Experience with Computerized Maintenance Management System (Blue Mountain Regulatory Asset Management preferable)

Other Qualifications:

o Strong oral and written communication skills

o Ability to work independently with minimal direction

o Self-directed and able to manage competing priorities

o Strong computer skills

o Ability to focus on a variety of issues and drive to results

o Ability to interact with a variety of organizational levels and foster cross-functional and cross-cultural team

o Knowledge with manufacturing quality (manufacturing, equipment, facilities, critical systems, automation, validation, etc.)

o Experience with Quality Assurance, CAPA, Change Control, Document Control, Training Systems

Pay Details: $50.00 to $67.00 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