Process Engineering Positions

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

BioTechnique is seeking a highly motivated Process Engineer (Mid-Level to Senior-Level) to support aseptic manufacturing, technology transfer, process validation, and continuous improvement activities within our sterile injectable CDMO operations. This role serves as a technical leader responsible for translating client manufacturing processes into robust, scalable, and compliant commercial operations.

The Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and Client Project Teams to support aseptic fill-finish programs from development through commercial production. The successful candidate will possess a strong understanding of aseptic processing, sterile manufacturing, cGMP requirements, process validation, and pharmaceutical engineering principles.

Lead process transfer activities from clients into BioTechnique manufacturing operations.

Develop manufacturing process strategies for aseptic fill-finish, sterile filtration, compounding, lyophilization, and packaging operations.

Author and review technology transfer protocols, reports, risk assessments, and process characterization documents.

Support engineering runs, water runs, media fills, and demonstration batches.

Manufacturing Support

Provide floor support during aseptic manufacturing campaigns.

Troubleshoot process deviations, equipment issues, yield losses, and process excursions.

Support investigations, CAPAs, and root cause analyses.

Drive process improvements that increase throughput, quality, and operational efficiency.

Provide technical leadership during critical manufacturing operations.

Process Risk Assessments

Analyze process data and recommend improvements based on statistical and scientific principles.

Evaluate smoke studies, environmental monitoring trends, contamination control strategies, and operator qualification programs.

Equipment & Facility Engineering

Support qualification and implementation of:

Visual inspection systems

Collaborate with Validation and Facilities teams during IQ/OQ/PQ activities.

Assess equipment performance and recommend improvements.

Review thermal characterization and freeze-drying data.

Support lyo process validation and technology transfer projects.

Lead Lean Manufacturing and Operational Excellence initiatives.

Utilize data analytics and process monitoring tools to improve performance.

Implement process robustness and reliability improvements.

Regulatory & Audit Support

Participate in client audits and regulatory inspections.

Provide SME support during FDA and customer inspections.

Prepare technical documentation for regulatory submissions when required.

Bachelor's degree in: Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, Related Engineering Discipline

4-8 years of pharmaceutical manufacturing experience

Minimum 3 years supporting aseptic manufacturing operations.

Sterile injectable manufacturing

Fill-finish operations

Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents

Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.

PTO, Sick Time, and Paid Holidays

Education Assistance

Pet Insurance

Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)

Financial Perks and Discounts

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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