Senior Process Engineer: Pharma Scale-Up & Tech Transfer

Adare Pharma Solutions; Vandalia (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan with company match

Paid time off

Tuition reimbursement

Life insurance

Flexible Spending Accounts (FSA)

Disability coverage

Job summary

Adare Pharma Solutions is seeking a Senior Technical Services Engineer in Vandalia, Ohio, to support solid oral dose manufacturing. The role focuses on development, process validation, tech transfer, and cross-site collaboration to scale up products for manufacturing.

Responsibilities include leading transfer projects, writing reports, training staff, and ensuring GMP adherence. A BS/BA in a related field with 3–5 years of experience is required, with strong problem solving and communication

Qualifications

• BS/BA degree from a four-year accredited university or college in Biology, Chemistry, Engineering, or related field; plus 3-5 years of related experience required.
• Possess mechanical aptitude.
• Must have good working knowledge of the “Good Manufacturing Practices.”
• Ability to continually learn on the job: new equipment, new manufacturing technologies, new raw materials, etc.
• Problem solving and trouble-shooting abilities. Ability to determine the root causes of failures and problems.
• Capable of scientific observation of processes; has ability to accurately record observations and draw conclusions from them.
• Technical writing ability. Ability to explain scientific and technical issues to a non-specialist audience.
• Excellent interpersonal written and oral communication skills.
• Proficient in Microsoft Office – Word, Excel, PowerPoint, Visio. Statistical software such as JMP.
• Ability to coordinate, contribute to, and work within cross-functional teams.
• Able to prioritize duties and work on multiple projects with minimal supervision.
• Possesses good attention to detail and excellent organizational skills.

Responsibilities

• Assist in running projects associated with product development, product and process optimization batches, and on completion to ensure robustness of the process and formulation.
• Train and mentor other technicians within the Formulations team.
• Work on special Formulations projects as requested.
• Coordinate and execute cleaning, process validation, and CMS technical / process operations activities with company quality units, operation, R&D and regulatory affairs for commercial or R&D products.
• Ensure sampling and testing are completed as planned.
• Assist in writing reports and preparing master formulary records.
• Follow protocol and batch records in manufacturing development batches and relate observations to CMS Manufacturing Associates and/or R&D Formulation group.
• Perform other duties as assigned. Manage scale up of commercial products, manufacturing feasibility batches, writing batch records and summarizing results for both internal and 3rd party manufacturing.
• Develop and execute studies for process, equipment, and cleaning validation activities related to bulk drug delivery and finished dosage formulations developed by Research and Development (R&D),products currently in commercial production, and technical transfers from customers or other Adare sites.
• Provide technical training and support to departments supported by the Technical Services/Validation departments (Third party GSC, Manufacturing, etc).
• Update, review, and approve Standard Operating Procedures (SOPs), batch records, and other official documents and determine if validation or re-validation is required prior to approval of the new or changed procedure(s). Recommend new procedures or revisions as applicable.
• Participate in Factory Acceptance Testing (FAT) and/or due diligence testing and investigations.
• Collaborate with validation projects within the facility including execution of protocols and report writing.
• Technical experience and/or expertise in the operation of pharmaceutical equipment including but not limited to tablet presses, blenders, fluid beds, roller compactors, pan coaters, mixers, ovens, capsule fillers, packaging equipment, and other pharmaceutical equipment.
• Operate independently and provide feedback and solutions to technical issues for both internal projects and projects at 3rd party sites.
• Support the engineering department with capital projects or trouble shooting of equipment and processes within the facility.
• Be a key contributor and practitioner of lean manufacturing programs within the facility.
• Attends work on a regular and predictable basis.
• Completes assigned tasks in a safe manner and in a constant state of alertness.
• Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
• Works in a cooperative manner with managers, supervisors, coworkers, customers, and the public.

Skills

Mechanical aptitude

Good Manufacturing Practices

Problem solving

Technical writing

Interpersonal communication

Microsoft Office

JMP

Cross-functional collaboration

Attention to detail

Education

BS/BA degree in Biology, Chemistry, Engineering, or related field

Tools

Microsoft Visio

JMP

Job description

Adare Pharma Solutions is seeking a Senior Technical Services Engineer in Vandalia, Ohio, to support solid oral dose manufacturing. The role focuses on development, process validation, tech transfer, and cross-site collaboration to scale up products for manufacturing.

Responsibilities include leading transfer projects, writing reports, training staff, and ensuring GMP adherence. A BS/BA in a related field with 3–5 years of experience is required, with strong problem solving and communication