Engineer II -(Associate)

Our client, one of the largest Pharmaceutical companies in USA is looking for Engineer II (Associate) at West Point, PA. Looking for someone with strong Deviation management, Technical Writing and someone who has run/led the investigations. 

Job Title: Engineer II (Deviation & Investigations)
Location: West Point, PA 19486 - once fully trained (training onsite 5 days a week) then will by hybrid 3 days a week onsite and 2 remote
 

MUST HAVES:

• This role will require Deviation Management work.
• Needs GREAT communication (written/spoken) skills.
• Deviation report includes gathering evidence, interviews with groups- needs to have comfort with investigations, asking questions (not afraid), gathering evidence.
• Good at technical writing

Job Description:

Qualifications:

• Education Requirements: B.S. or B.A. in Engineering, Sciences, or related discipline. 2-4 yrs experience (combination of co-op/Real world acceptable).

Required Experience and Skills:

• Strong Technical Writing Skills
• Highly developed communication, Leadership and teamwork skills
• Ability to manage projects/work to schedule/deadlines.

Preferred Experience and Skills

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities,
• Change Control experience
• Deviation Management Investigation.

Responsibilities:

• Authors, supports, updates, and/or leads documentation updates such as SOPs, batch records, change control documents, technical protocols, validation documents and other GMP documentation
• Supports deviations, including assessment of product impact and determination of root cause and corrective/preventative actions, assists in writing of investigations as well as quality incidents.
• Supports equipment, and facility projects for various Sterile Supply Departments at the West Point site.
• Supports continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process.
• Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.
• Designs, conducts, and/or reviews and approves experimental protocols as needed.
• Provides on-the-floor support of complex operational and technical (process/equipment) issues.
• Completes and/or leads projects to improve the performance of our Company processes, including investigation and execution of Corrective/Preventative Actions (CAPAs); projects aimed at improving Right-First-Time performance or preventing/reducing deviations; and projects that seek to improve efficiency, reduce cost, or increase compliance.
• Supports team safety, environmental, and compliance objectives.
• Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.
• Partners effectively with Operations, Quality, Planning, project teams, and external vendors.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of:  Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.