Senior Manufacturing Engineer

Type: Contract, W2 only

Duration: 12 months with possible extension/conversion

Location: onsite in Branchburg, NJ

Pay: $46/hr-$80/hr, DOE

Travel: 10-20%, based on business needs for the first 4-6 months.

Please note that at this time we are unable to sponsor employment authorization (both new and transfer)

A global biotechnology leader is seeking a Senior Manufacturing Engineer to lead initiatives that optimize and advance high-speed GMP manufacturing operations. This role involves defining equipment and packaging specifications, ensuring alignment between production capabilities and marketing goals, and applying both engineering expertise and financial insight to improve quality, efficiency, and cost performance. The ideal candidate will have hands-on experience with automated filling and packaging systems, equipment installation, and startup within GMP environments. Key objectives include ensuring automated systems meet specifications and are production-ready, reducing downtime and repair times, and improving overall throughput and yield.

Responsibilities:

• Plan and manage project activities for projects within filling and packaging manufacturing streams.
• Define specifications for new equipment and packaging components in accordance with manufacturing capabilities and marketing objectives.
• Apply engineering principles and financial expertise to improve diagnostic manufacturing performance, promote cost reductions and achieve optimum level of quality and efficiency.
• Establish New Equipment and Processes: use technical and business knowledge and expertise to support Operations in the design, maintenance, installation, scale-up, optimization, automation, trouble shooting and validation of manufacturing processes or equipment. Aid in the preparation of user requirements, bid package, capital justification, and acceptance testing strategy for all new filling, packaging and manufacturing equipment.
• Assess production processes for quality improvement opportunities, ensuring compliance with cGMP and ISO standards.
• Manufacturing Documentation: creation of a variety of documentation used to support product launches and manufacturing, including but not limited to filling records, packaging records, manufacturing records, packaging development purchasing specifications and SOPs. Initiate and oversee change requests and design change requests as needed.
• Lead cross-functional project teams for complex projects within operations. Monitor, facilitate and prioritize activities to meet project schedules. Activities include: communicating project status and critical path items to Operations Management, develop and implement timeline plans, convening periodic meetings, issuing meeting agendas and minutes, monitoring team performance goals, and assisting in resolution of problems/critical issues. Work with and lead cross-functional teams consisting of 5-10 people.

Knowledge Skills and Abilities:

• Bachelor's degree in Engineering or related technical discipline with 5-6 years of related experience, background and industry, or M.S degree with 4 years of related experience, background and industry.
• Hands-on experience in a cGMP manufacturing environment with automated filling and packaging equipment.

Preferred:

• Experience in drafting and executing equipment qualification protocols (IQ/OQ/PQ) and test method validations.
• Experience with surface treatment (i.e. plasma, CO2 cleaning), adhesive bonding, drying methods and microdispensing.
• Experience with injection molding of primary packaging components.
• Experience managing projects in a matrixed organization.
• Working knowledge of pharmaceutical/medical device/diagnostics cGMPs and FDA compliance is strongly preferred.
• Experience with design transfer activities for medical devices.
• Experience implementing automation equipment.
• Material Science knowledge.

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs