Msd
Senior Specialist, Automation Engineering (Onsite)
USA - New Jersey - Rahway · Senior · Contract
Sponsorship not specified$117k-$184kDetected 5 days ago
PythonData AnalysisA/B TestingProject ManagementVendor ManagementHRISCustomer SupportPLCGMPLeadershipCommunicationProblem SolvingWritingSCADA
About the role
- Please click here if you need an accommodation during the application or hiring process.
- The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
- We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Responsibilities
- Maintain automation systems in a validated, compliant state per cGMP, Safety, data integrity, cybersecurity, and lifecycle best practices (commissioning, qualification, change control, obsolescence, periodic reviews)
- Provide end-to-end operations support for sterile clinical manufacturing (formulation and filling/lyophilization), including on-floor troubleshooting, root cause analysis, and performance/batch reliability improvements
- Implement and sustain platform automation solutions, reporting, and visualization to meet operational and compliance needs; keep documentation, SOPs, drawings, configurations, PMs, and inventories inspection ready.
- Lead and participate in automation system changes, investigations, CAPAs; represent automation and data integrity during internal/external audits and inspections.
- Develop and execute automation change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
- Serve as site automation representative for new products, process changes, and operational improvements; lead cross-functional teams and participate in tier meetings to drive continuous improvement.
- Lead and coordinate installation, integration, FAT/SAT, commissioning, and qualification (AIOQ) of new automated equipment and systems; author/execute URS/RS/CS/DS/AIQ/AOQ/AIOQ/UAT.
- Partner with enterprise/divisional IT, global infrastructure, and risk/security to align standards and manage user/role administration, patching, backups, disaster recovery, and virtualization in GMP operations.
- Collaborate with GES, FM/GWES, Quality (product/equipment QA and digital data quality -DDQ), Manufacturing Operations, OEM vendors/system integrators to deliver reliable, compliant automation operations.
- Supervise and coordinate contract engineers/vendors and manage workload and deliverables.
Nice to have
- Demonstrated a strong performance record and have excellent project management skills.
- Highly developed communication, leadership and teamwork skills
- Experience with electronic validation and quality systems (e.g., Kneat/eVal, Veeva)
- Prior leadership of installation/integration/qualification of automated equipment
- experience on capital projects in GMP environments
- Familiarity with planning/scheduling practices, vendor management, and business/financial acumen for project delivery
- Track record of independent ownership, prioritization, and delivery in a fast-paced clinical manufacturing setting
- Demonstrated experience supporting audits/inspections and authoring/reviewing SOPs, validation protocols/reports.
Skills
- Proven root cause analysis and problem-solving skills; continuous improvement mindset.
- Current Employees apply HERE
- Current Contingent Workers apply HERE
- Preferred Experience and
- Platforms/
- Programming: Ladder Logic, Sequential Function Charts, Python and/or other scripting for automation, testing, and reporting
- Knowledgeable of S88 batch standards.
- Experience in biologics, vaccine or bulk sterile manufacturing facilities is strongly preferred.
- OT/IT: Industrial networking, virtualization (e.g., VMs), databases/historians, and basic system administration
Compensation
- The salary range for this role is
Benefits
- Develop and support data, reporting, analytics, and visualization solutions using historian/SCADA sources to monitor asset health and drive reliability improvements.
- Education Minimum Requirement:
Company info
- Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
- As 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 applicable legally protected characteristics.
- As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
- For more information about personal rights under the U.S.
- We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
- Search Firm Representatives Please Read Carefully
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
- All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
- No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
- Where agency agreements are in place, introductions are position specific.
- Please, no phone calls or emails.
Equal opportunity
- Employment laws, visit:
- EEOC Know Your Rights
- EEOC GINA Supplement
- We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Visa & Work Authorization
- VISA Sponsorship:
This listing is sourced directly from Msd's careers page and normalized into a canonical job model.