Associate Specialist Equipment Design and Facilities Engineering (Onsite)

Job Description

Role Summary:

The Chemical Engineering Research & Development department is seeking an engineering associate specialist for the Equipment Development Facilities Engineering team to primarily act as a maintenance team member supporting the API Development facilities including but not limited to the 800 Prep Lab as well as potent development labs in Bldg. 800 818 and 80R. These are potent multi-modality (small molecule macrocyclic peptides bioconjugates) Drug Substance development and GMP clinical manufacturing facilities located in Rahway New Jersey. Responsibilities include day-to-day support of lab facility and equipment therein including reliability operability/maintainability and execution of capital and expense projects to enhance facility compliance new processing technologies and production capacity.

Key Functions:

• Maintain lab and utility equipment by developing and executing maintenance strategies
• Perform day-to-day technical oversight of both internal and 3rd party maintenance teams
• Work with lab process teams to support planning scheduling and execution of routine corrective/preventive maintenance and facility annual shutdown activities
• Demonstrate a strong Compliance mindset through application of learned knowledge of cGMP and Safety requirements

• Support asset compliance status and disposition via use of computerized maintenance software
• Interact with Quality groups to support audits qualify equipment and maintain readiness to perform GMP work
• Build expertise to ensure effective safe and compliant equipment/process setups with line of Sight to the Pilot Plants
• Leverage learned knowledge to support equipment troubleshooting efforts

• As part of a team execute equipment reliability initiatives facility improvement projects and new technology implementation in support of development pipeline programs (typ. range of $10K to <$1MM scale) and
• Support and build skills for incident root cause analysis including documentation reporting and action item management.

Education and Experience Minimum Requirements:

• BS in Engineering with 1 years of experience in Facility Maintenance and/or Project Management

Required Experience and Skills:

• Strong mechanical aptitude
• Demonstratable knowledge of facilities and equipment from an operations and maintenance perspective
• Familiarity with Process Flow Diagrams and/or mechanical drawings
• Effective communication and collaboration skills
• Ability to gather data evaluate potential options and make recommendations to support decision making
• Ability to learn contribute and in some cases lead problem-solving efforts and
• Fluent in Microsoft Office use of email and meeting facilitation

Desired Experience and Skills:

• Knowledge of Change Management processes and principles
• Experience interacting with skilled trades (Piping Electrical Millwrights Instrumentation 3rd party contractors and vendors)
• Maintenance experience in GMP environments including familiarity with US and EU Safety and GMP compliance regulations
• Experience operating/maintaining lab scale equipment
• Ability to read and understand P&IDs
• Experience with Potent Compound processing and containment systems (e.g. isolators) or clean room facilities
• Trained in use of Hexagon EAM for Plant Maintenance and SAP for Financial Business Systems management
• Experience with Process Analytical Technology (PAT)
• Familiarity with Electrical Classifications for solvent and dust (Class I and II Div I and II)
• Experience working in a facility governed by Standard Operating Procedures (SOP) and/or cGMP documents and
• Experience with high-risk work including but not limited to Lockout/Tagout Hazardous Energy Control Elevated Work and Confined Space Entry

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Where required by law the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Companys reasonable expectation of the base salary applicable to this role at the time of posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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