Pharma Project Engineer - System Lead SUM, PW , AC

The Spear Group Full-Time Opportunity w/ Benefits

Position: Pharma Project Engineer, Systems Lead – Single Use Mixers, Parts Washers & Autoclaves

Location: Greater Philadelphia, PA / Villanova Area & Wilmington, Delaware

Position Summary:

The Spear Group has an exciting life sciences owner’s side opportunity for an experienced Project Engineer System Lead– Single Use Mixers, Parts Washers & Autoclaves. This role can encompass project end to end responsibilities, but the role starts with project front end work encompassing project SME design & design review. This position supports The Spear Group’s world class biopharma client with a major capital project in the Greater Philadelphia, PA, 2 years / Wilmington, Delaware area, remaining years. This role starts with the planning & design initiation along with the design review phase of the project which will be based in the Greater Philadelphia, PA. area. This role has the option to continue on the project, on site in Delaware, through the remaining phases of the project (construction & close out). This System Lead Project Engineer role will be responsible for design, design review, user requirements, submittals, design integration, specifications, FAT’s, and P&ID reviews.

Key Responsibilities:

• The Project Engineer System Lead is responsible for designing / design review, developing, and testing components, machinery, and equipment associated with Single Use Mixers ( SUM ), Parts Washers & Autoclaves using applied knowledge of engineering principles.
• The successful candidate will be part of a project multi-functional team charged with the delivery of the capital project and will be accountable for all front-end aspects of this specific system.
• Responsible for technical leadership for new Parts washers, Autoclaves, SUM's (single use mixers) and FIT's along with all supporting ancillary equipment within the equipment preparation and formulation areas from design stage to successful PPQ of all products within the facility.
• Ensure that design and start-up project scope and timelines meet the user requirements and work with the project teams to facilitate delivery, validation and safe operation of new Parts washers, Autoclaves, SUM's (single use mixers) and FIT's and other supporting equipment / processes.
• Will be acting area SME in support of reviews.
• Will have an in-depth knowledge of process operations and process equipment to support Manufacturing, Quality, Automation, Validation, and EHS.
• Technical expert for system and equipment and accountable for changes to ensure continued compliance of the manufacturing equipment
• Ensuring all the systems are in compliance with all Regulatory requirements including Quality (cGDP/GMP's), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements.
• Part of a cross-functional project team, providing key Process Systems / Equipment SME input during design stage and the role will have the option to provide continuing SME Systems / equipment engineering support as required, during execution, construction, and closeout stages.
• identify user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
• Provide technical expertise ensuring compliance to regulatory requirements, industry best practices, and engineering standards.
• Anticipate operational gaps (improvements to systems / facility / equipment design, process inefficiencies, job hazards) rather than scrambling to fix issues in the project startup, leading to a smoother and safer transition to the end user team.

Required Experience and Education:

• The successful candidate must possess a bachelor’s degree in engineering and 5-15 years’ experience with Pharma/BioPharma manufacturing.
• Deep technical knowledge of the specified system with project design experience required. Technical knowledge from both a process and equipment perspective. Specifically in the areas of system / equipment preparation and formulation.
• Experience with single use systems.
• Knowledge of the current pharma manufacturing industry practices and regulatory requirements.
• Familiar with start-up of new Drug Product manufacturing facility projects from initial design through to the final qualification of the equipment and process.
• First-hand experience of design & qualification of system, equipment, and process specifically in the areas of equipment preparation and formulation
• The candidate will have demonstrated proficiency communicating and collaborating at a variety of levels and project professionals, coupled with excellent organization and planning skills.
• Problem solving and capital project engineering successful collaboration ability and experience as well as lean manufacturing knowledge and experience is essential.
• Strong mechanical aptitude.
• Demonstrated ability to resolve system technical challenges in project phases.
• Excellent interpersonal and communication skills.
• Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
• Interact well with other project functional areas and must be able to take ownership of and follow through on assigned area of systems and equipment expertise with minimal required direction.
• Willingness to adapt to changing project priorities as project evolves.
• SME-level knowledge of specified system (e.g. single-use mixers, parts washers, and autoclaves, etc).
• Direct experience ordering capital equipment, materials required for production and spare parts a plus.
• Previous experience working on large / major / high dollar amount pharmaceutical manufacturing facility and processing capital projects.

Compensation based on relevant experience

EQUAL OPPORTUNITY EMPLOYER

The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are affected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our workforce and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.