Process Engineer in Andover, MA

1st shift 6am -6pm, rotating

What is the minimum education experience required?

• Bachelor's Degree
• 2 + years Experience within the pharmaceutical industry
• Master’s Degree

Why Patients Need You

• Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team.
• We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Client’s mission.
• Patients need colleagues like you who take pride in their work and always look to improve outcomes.
• You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

• You will have knowledge of process equipment and systems and manufacturing operations with the primary responsibility to execute process and equipment operation activities during manufacturing operations.
• Due to your expertise in the manufacturing domain, you may participate in training for operational qualifications and assist the Team Lead or other team members as needed.
• You will conduct all activities in accordance with Company policies and standard operating procedures, Client Values, and global regulatory guidelines, environmental guidelines etc.
• As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
• It is your hard work and focus that will make Client ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to completion of project milestones and organize own work to meet project task deadlines.
• Use operational and technical expertise to assist in troubleshooting activities, technology transfer and start-up activities.
• Monitor the technical documentation for the production and processes approval.
• Ensure all production equipment and systems are in compliance with {Current} Good Manufacturing Practices.
• Manage execution of relevant process activities by following established Standard Operating Procedures.
• Perform process monitoring and data analysis, and data preparation for presentation in several forums including project team meetings.

ROLE RESPONSIBILITIES

• Individual will provide subject matter expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment to moderately complex process and equipment change controls to ensure a robust and capable solution.
• Individual will be expected to participate and drive in continuous improvement and innovation initiatives.
• Individual is expected to be an M1 lead.
• Individuals will be required to display multi-tasking skills.

Qualifications

Must-Have

• 2+ Bachelor's Degree
• Experience within the pharmaceutical industry
• Effective verbal and written communication skills
• Mechanical knowledge and the use of hand tools

Nice-to-Have

• Master’s Degree
• Demonstrated ability to train and coach others
• Experience with Six Sigma or other operational excellence programs
• In-depth knowledge of drug substance/drug substance intermediate manufacturing technology

PHYSICAL/MENTAL REQUIREMENTS

• Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
• Must have the ability to lift ~50 pounds.
• The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam and/or corrosive chemicals.
• The incumbent is required to attain detail knowledge of the operational equipment.
• The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.
• The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.

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