Associate Design Engineer Jobs in Culpeper, VA (NOW HIRING)

We have an exciting opportunity for an Associate Director, Technical Operations – Drug Substance at our Elkton Site in Virginia, USA.

At our company, we aspire to be the premier research‑intensive biopharmaceutical company, using leading‑edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose‑built, agile small‑molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast‑following into production with a focus on quality, safety, and operational excellence.

• Technical Leadership
  • Recognized subject‑matter expert in Drug Substance process support and commercial manufacturing.
  • Provide technical oversight and hands‑on leadership for API manufacturing processes, including chemical synthesis, purification, crystallization, and drying operations.
  • Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness.
  • Lead process scale‑up, technology transfer, and validation (pre‑PPQ, PPQ) activities for assigned processes.
  • Drive improvements in process performance, yield, robustness, and impurity control.
  • Provide technical guidance on process chemistry, reaction performance, and critical process parameters and control strategies.
  • Analyze technical data and support decision‑making for process performance and improvements.
  • Identify and mitigate risks, proposing practical, science‑based solutions.
• Technology Transfer
  • Lead and execute technology transfer activities for assigned processes across internal sites and external partners.
  • Support development and execution of tech transfer plans aligned with project timelines.
  • Provide technical support for raw material evaluation, process fit and manufacturability, and scale‑up readiness.
  • Ensure accurate process documentation, knowledge transfer, and batch record readiness.
  • Support process validation and continued process verification.
• Operational Excellence
  • Partner with Manufacturing to ensure safe, efficient, and reliable plant performance.
  • Provide direct technical support for campaign preparation, execution, and follow‑up, and process troubleshooting during manufacturing.
  • Lead and support deviation investigations, OOS, and CAPA, applying structured root‑cause analysis.
  • Monitor process performance and cycle times, identifying improvement opportunities.
  • Drive continuous improvement initiatives for yield, cycle time, and cost.
  • Support process optimization and debottlenecking activities.
• Regulatory & Compliance
  • Ensure assigned processes operate in compliance with cGMP and regulatory expectations.
  • Support inspection readiness and audit activities.
  • Contribute to regulatory submissions and responses, including data generation and technical input.
  • Ensure data integrity and adherence to quality and safety standards.
  • Maintain compliance from startup through commercial operations.
• Cross‑Functional Leadership
  • Collaborate with Engineering, Capital Projects, R&D, Quality, Supply Chain, and Manufacturing.
  • Act as a technical representative for assigned processes within cross‑functional teams.
  • Support technology transfer and process improvements across the network.
  • Participate in interactions with external partners and CMOs as required.
  • Contribute to technical reviews and governance forums.
• People, Capability & Business Leadership
  • Lead and develop a team of technical specialists and engineers.
  • Provide coaching, technical guidance, and performance feedback.
  • Support resource planning and execution of departmental priorities.
  • Contribute to budget tracking and departmental administration.
  • Support recruitment, onboarding, and capability development initiatives.

• Degree (BSc/BEng/Masters) or higher in Chemistry, Chemical Engineering, or a related discipline.
• Significant experience (typically 10+ years) in API process development and/or manufacturing.
• Strong background in process chemistry and scale‑up, process, equipment, and cleaning validation.
• Working knowledge of cGMP manufacturing operations and regulatory expectations and inspection readiness.
• Experience with deviation management and investigations, electronic batch records, and process systems (e.g., DeltaV).
• Exposure to capital projects, CQV, and facility startup.
• Strong analytical, problem‑solving, and communication skills.
• Ability to work effectively across cross‑functional teams and multiple priorities.

• Adaptability, Automation Systems, Batch Processing, Biopharmaceutical Industry, Business Management, Capital Project Management, Change Management, Chemical Engineering, Clinical Manufacturing, Commercialization, Data Analysis, Data Integrity, Decision Making, Drug Product Manufacturing, Interpersonal Relationships, Knowledge Transfer, Lean Manufacturing, Manufacturing Scale‑Up, Operational Excellence, Process Documentation, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking.

We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world’s most challenging healthcare needs. We believe breakthrough innovation happens when experienced leaders empower talented teams in an inclusive environment.

Salary Range: $142,400.00 – $224,100.00. The range is the lowest to highest salary we in good faith believe would be paid for this role at the time of posting.

Benefits: Medical, dental, vision, healthcare, retirement (401(k)), paid holidays, vacation, compassionate days, sick days. Additional details are available at https://jobs.merck.com/us/en/compensation-and-benefits.

Eligible for annual bonus and long‑term incentive, if applicable.

We are an Equal Employment Opportunity Employer. We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.

Job Posting End Date: 08/15/2026

Travel Requirements: 10%

Relocation: Domestic