Project Manager Senior

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Job description

Summary:

Looking for a Senior level PM who will support manufacturing plant and engineering group, this person needs to have process/utility Engineering technical experience and not only be quality background driven.

The engineers will lead project engineering and construction activities in alignment with the engineering workstreams (i.e. Trades during construction, project management budget, schedules, safety, and client's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & facilities design and compliance, project management, etc.).

Day to Day Responsibilities:

The engineer will lead project engineering and construction activities in alignment with the engineering workstreams (i.e. Trades during construction, project management budget, schedules, safety, and client's

Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & facilities design and compliance, project management, etc.).

The staff works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.

The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance.

The position will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.

Preferred Qualifications / Skills / Experience:

Bachelor's degree in engineering or another science-related field

2+ years of relevant work experience with 1+ years' experience in operations/manufacturing environment

Direct experience with regulated environments (FDA, OSHA, EPA, etc.)

Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment

Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution

Experience with combination product / medical device quality systems verification

Process equipment knowledge - cell culture, fermentation, purification, filling, and packaging

Process automation knowledge - understanding of automation infrastructure, current technologies, and automation project execution / verification.

Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus

Demonstrated strong communication and technical writing skills

Strengths in facilitation and collaboration / networking

Experience in developing SOPs and delivering training

Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making

Good record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)

Demonstrated skills in the following areas:

Problem solving and applied engineering.

Basic technical report writing.

Verbal communication

Top 3 Must Have Skill Sets:

Looking for a Senior level PM who will support manufacturing plant and engineering group, This person needs to have process/utility Engineering technical experience and not only be quality background driven.

Demonstrated problem solving and applied engineering skills

Strong teamwork

Strong communication

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.

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