Process Controls Engineer – Biopharma

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: Process Controls Engineer – Biopharma

Location: Portsmouth, NH, 03801

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: First Shift

Pay Range: $75 to $85 Depending on experience

Summary:

This is a Technical engineering role providing support to pharmaceutical/biotechnology manufacturing operations, with a primary focus on manufacturing and process automation systems, instrumentation, and equipment. Serves as a technical resource to Operations and supports troubleshooting, technical analysis, technology transfers, projects, process improvements, quality issues, change controls, and lot-release activities. Works closely with Manufacturing, Engineering, and Quality Assurance teams to maintain reliable manufacturing operations and compliance with cGMP, safety, and site requirements.

Responsibilities:

• Provide technical support to manufacturing operations related to process automation systems, instrumentation, and equipment.
• Troubleshoot manufacturing equipment, automation systems, and control systems to support production requirements.
• Develop and maintain strong technical knowledge of manufacturing equipment and process automation systems.
• Support technology transfers, automation projects, process improvements, and other technical initiatives.
• Assist with the resolution of equipment breakdowns, manufacturing issues, and quality issues.
• Perform technical analyses, including PI data analysis, to support manufacturing troubleshooting and process improvements.
• Review and troubleshoot automation/control system code.
• Provide technical support during normal business hours and participate in an on-call rotation when required.
• Participate in IPT/JPT meetings and other cross-functional meetings as the Controls representative.
• Initiate and participate in all aspects of the change control process.
• Complete change request lot assessments to support lot-release activities.
• Review SOPs, Functional Specifications, and Work Instructions.
• Support manufacturing troubleshooting while identifying potential safety hazards and kinetic energy sources.
• Ensure adherence to cGMP requirements during API manufacturing activities.
• Report regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions to responsible management.
• Collaborate closely with Manufacturing, Engineering, and Quality Assurance teams.
• Maintain compliance with assigned training requirements and applicable site procedures.
• Follow all applicable safety procedures and promote a strong safety culture.
• Perform other duties as assigned.

Required Skills:

• Bachelor’s degree in an applicable Engineering field or Computer Science.
• 5–10 years of experience in pharmaceutical, biotechnology, or equivalent industrial automation environments.
• Advanced experience with manufacturing and process automation systems.
• Strong knowledge of instrumentation and automation systems.
• Hands-on experience troubleshooting manufacturing equipment and automation/control systems.
• Experience with PI data analysis.
• Ability to review and troubleshoot automation/control system code.
• Knowledge of pharmaceutical or biotechnology manufacturing processes.
• Working knowledge of cGMP requirements and pharmaceutical quality standards.
• Experience with change control and lot-release processes.
• Ability to interpret and work with SOPs, Functional Specifications, and Work Instructions.
• Strong critical-thinking, logical problem-solving, analytical, and technical troubleshooting skills.
• Experience supporting continuous improvement, technology transfer, and automation projects.
• Proficiency with Microsoft Office Suite, particularly Outlook, Word, and Excel.
• Strong communication and collaboration skills.
• Ability to work effectively with Manufacturing, Engineering, and Quality Assurance teams.
• Ability to work independently under general supervision.
• Ability to establish appropriate methods and procedures for achieving technical objectives.
• Business-fluent English communication skills.
• Knowledge of safety procedures and ability to identify potential manufacturing safety hazards.
• Ability to work effectively in a regulated pharmaceutical/biotechnology manufacturing environment.
• Willingness and ability to participate in on-call support when required.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.