Process Equipment Engineer

STA Pharmaceutical

About The Position

This position will be part of DP engineering team under WuXI STA, The role will design, develop, optimize and manage execution the whole lifecycle activities of GMP drug product manufacturing and packaging process including equipment at our Middletown, Delaware site. This may include support of CQV programs for manufacturing/packaging equipment, instruments, utilities, and processes. The Engineer is also responsible for ensuring external and internal quality standards are applied and followed.

Requirements

3 - 5 years of experience in a Process or Equipment engineering role, preferably in the pharmaceutical drug products manufacturing industry.
Ability to read and understand engineering drawings such as P&IDs, equipment/facility layout drawings, electrical/pneumatic drawings, and functional specifications.
Bachelor’s degree in Engineering (preferably in Mechanical, Electrical or Chemical Engineering).
Thorough understanding of cGMP and FDA requirements
Strong communication and documentation skills
Proven project management skills
Experience with equipment qualification following ISPE and ASTM guidelines.
Proficient with Microsoft Office Suite, Maximo, Calibration program software, MES, etc.
Technical: Strong understanding of engineering principles, process design and optimization, quality control, pharmaceutical manufacturing technologies, equipment, and relevant software. Knowledge of cGMP guidelines and regulatory compliance is essential.
Analytical & Problem-Solving: Ability to analyze complex processes and data, identify bottlenecks, troubleshoot issues, and develop effective solutions.
Soft Skills: Excellent communication (written and verbal), teamwork, leadership, project management, organizational abilities, time management, adaptability, attention to detail, critical thinking, and negotiation skills.
Industry Specific: Familiarity with FDA regulations, cGMP guidelines, Lean Manufacturing, and risk assessment techniques (HAZOP, FMEA).

Nice To Haves

Prior experience as an equipment or process engineer with process control systems and troubleshooting of pharmaceutical manufacturing process and packaging equipment.
Familiarity with Sterile F/F equipment qualification is a plus.
Familiarity with IOQ/PQ of process/packaging equipment for the pharmaceutical industry.
Familiarity with Maximo or equivalent Regulatory Asset Manager software.

Responsibilities

The role will be responsible for managing and executing the site manufacturing equipment project and its lifecycle management.
Be part of project team as manufacturing system owner, lead to identify, design, supervise and verify manufacturing system to meet process development, production and EHS requirement, and comply with all relevant regulation.
Lead to develop and establish programs for OSD/Sterile manufacturing system and other assigned system maintenance and calibration plan and manage execution, included but not limited on the system documentation, operation resources, technical services, training and material planning etc.
Leads cross functional teams in completion of system impact evaluations and system risk assessments in a multi-product facility. Performs gap assessments and remediates new risks as new equipment and/or products are introduced.
Ensuring compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations.
Conducting risk assessments and supporting equipment/utilities qualification activities.
Hands-on experience with troubleshooting and resolving process equipment-related issues during production.
Experience managing equipment Preventative maintenance, Calibration, and reliability programs independently with minimum supervision.
Experience with OSD equipment but not limited to Wet Granulation systems, Bin Blenders, Encapsulation, Tablet Presses, Tablet Coaters, Roller Compactors, etc. is a must.
Experience in packaging equipment like bottles packaging, blisters packaging, powders packaging, etc.
Collaborating with cross-functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs.
Experience in writing Change Controls, Investigation reports, Work Orders, CAPA, Standard Operating Procedures (SOP), and risk assessments.
Analyzing process data and driving continuous improvement initiatives to enhance efficiency, reduce costs, and improve product quality.
Providing technical support and training to production staff on new processes, equipment, and safety protocols.
Identifies and proposes process improvement ideas and collaborates with cross-functional teams to meet project deliverables and timelines, including scheduling, testing, and deviation resolution.
Performs other related duties as assigned.