Senior Project Engineer

This Engineer Senior Specialist (P3) position will provide compliance project engineering leadership for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, including the RY119 Development center and the WP Sterile Liquids pilot plant under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations & Clinical Supplies (Pharm Ops) organization.

Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.

The SLP and FLEx facility supports the formulation and filling of clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products, vaccines and sterile forms, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization.

Primary responsibility will be to lead execution of project management (capital and expense) and administration in support of new equipment purchases and existing equipment modifications.

This will include working with the scientist and formulators, original equipment manufacturers (OEMs) and project engineering groups (GES) to specify, design, build and install the required equipment to increase capability for Pharm Science or implementation of technologies to existing equipment or facilities, to meet potent handling and Industrial Hygiene (IH) compliance requirements.

Other responsibilities will include support of departmental (Pharm Sci) Capital Management, Engineering initiatives, Safety Compliance initiatives and metrics, assisting in safety investigations and root-cause analysis (RCA), as well as support of various departmental program actions : Process Safety Management (PSM), IH Compliance plans, etc.

that typically require actions on an annual basis.

The candidate will provide administrative oversight support in terms of SAP Capital Project Administration and interact with Enablon, E-Val and QMS.

The candidate will support communication and partnering efforts with Global Engineering Solutions (GES), Global Safety & Environmental (GSE), as well as at-site partner groups (GWES, Sodexo, etc.).

Minimum Qualifications :

Bachelor's Degree in Engineering or Science plus a minimum of 5 years of Drug Product or related experience.

Required experience and skills :

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Strong familiarity with Capital Project management & execution.
• Must have demonstrated experience executing capital projects.
• Ability to flow to the work across projects and support multiple projects simultaneously.
• Effective organizational skills.
• Effective communication.

Preferred Experience and Skills :

• Experience with our company's GES Engineering Standards & Guidelines.
• Experience with our company's GSE Safety & Environmental Standards and Guidelines.
• SAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance.
• Experience with ProCal as a Computerized Calibration Maintenance System (CCMS).
• Familiarity with Planning and Scheduling practices as well as business / financial practices.
• The candidate should be able to work independently and lead or facilitate tasks successfully.

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