Position Summary
We are seeking an experienced Project Manager to support automation-related projects within regulated and fast-paced operational environments. This role will be responsible for planning, coordinating, and overseeing projects from initiation through completion, ensuring alignment with business objectives, timelines, budgets, and compliance requirements. This position is offered under Contract Services / Professional Services engagement. Position Responsibilities
Requirements
Preferred Qualifications
Work Arrangement
Equal Employment Opportunity Statement We are an Equal Opportunity Employer and are committed to creating an inclusive environment for all employees and contractors. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other protected characteristic under applicable federal, state, or local laws.
Position Overview
The Project Coordinator will support the execution of capital and operational projects within a regulated manufacturing/pharmaceutical environment. This role is primarily field-based and responsible for coordinating and overseeing project activities to ensure compliance with safety standards, cGMP regulations, company policies, and project requirements.
The incumbent will manage multiple well-defined projects and assignments, while supporting larger, more complex projects under the guidance of the Project Manager, from initial concept through final close-out.
Key Responsibilities
Coordinate and execute multiple multi-disciplinary projects from initiation through completion in support of site operations.Support the Project Manager in all project phases, including planning, cost estimating, bidding, scheduling, safety metrics, and cash flow tracking.Oversee field execution to ensure projects are delivered in compliance with company standards, SOPs, and regulatory requirements (cGMP/cGLP/cGCP, as applicable).Monitor project progress, identify technical issues, and collaborate with the Project Manager to develop and implement effective solutions.Ensure adherence to safety policies and promote a strong safety culture across all project activities.Coordinate project-related communication across cross-functional teams to facilitate timely and efficient execution.Assist in the development and review of project design documentation, including coordination with external A&E firms for drawings, specifications, and deliverables.Support design review meetings, document control processes, and transmittal of project information.Assist in the preparation of project cost estimates, including labor, materials, equipment, and installation.Support the development of bid packages for construction, equipment procurement, and facility expansions.Oversee contractor activities in the field, ensuring compliance with project scope, drawings, specifications, schedules, and safety requirements.Verify that contractors receive appropriate site orientation and adhere to all regulatory and safety standards.Ensure proper documentation of project activities and timely reporting of project status.Minimum Requirements
Associate Degree in Engineering or related technical field (Bachelors Degree preferred).Minimum of five (5) years of experience in a Project Coordinator, Project Foreman, or similar role.Experience in regulated industries such as pharmaceutical, biotechnology, or medical device manufacturing is required.Working knowledge of cGMP and regulatory compliance requirements.Experience supporting construction, facilities, or capital projects within a manufacturing environment.Strong organizational, communication, and problem-solving skills.Ability to work in a fast-paced, field-based environment and manage multiple priorities simultaneously.Preferred Qualifications
Experience coordinating with external engineering/design firms (A&E).Familiarity with project management tools (e.g., MS Project).Knowledge of cost control, scheduling, and contractor management.OSHA or safety-related certifications are a plus.Work Environment
Primarily field-based role within a manufacturing/pharmaceutical facility.Requires oversight of on-site project execution and coordination with contractors and internal teams. Read Less Oversee and coordinate well-defined multi-disciplined projects from inception to project completion in support of site operations ensuring safety, regulatory compliance, company standards, operational requirements and business needs. Coordinate information across the project team to facilitate project facilities execution. Prepare routine project status reports. Apply engineering principles and methodologies to project and support work. Identify technical problems and develop problem-solving solutions.
Apply cGMP principles for the workplace. Incorporate cGMP and regulatory compliance into all assigned project scopes, design and construction activities. Promote safety within the workplace by following site safety procedures. Incorporate safety into all assigned capital projects.
Coordinate and oversee development of assigned project design documents. Select A&E firms to perform engineering design. Coordinate and review work with outside A&E firm relating to designs and deliverables (drawings, specifications, etc.). Coordinate team review of designs. Coordinate design meetings, transmittal of information and document review. Define and document team decisions.
Prepare project estimates for design, equipment, installation, labor, materials, and other related costs. Work with Purchasing to prepare bid packages for construction and facilities expansion. Prepare project forecasts and schedules and tracks costs.
Oversee assigned project contract work. Review and approve project contractor bids, request for information, submittals and change requests. Inspect work progress to ensure conformance to established drawings, specifications, schedules, and safety regulations. Assure contractors receive necessary orientation and training.
Bachelors Degree in Engineering
Masters Degree in Engineering (Preferred)
More than wight (8) years of experience in Construction Project Management.
Technical Services Packaging Specialist
Job Purpose
Applies advanced technical process solutions in packaging technology and processes, ensuring priorities are aligned with customer needs, technology management objectives, company goals, and government regulations. Implements new packaging technologies for the site and leads all packaging process qualifications and validations.
The incumbent must be capable of leading cross-functional projects with some direct involvement from their supervisor. This role involves troubleshooting and resolving moderate to highly complex packaging process issues, diagnosing technical problems, and determining both short- and long-term solutions.
All packaging projects must achieve business, quality, and compliance objectives and be executed in full compliance with government regulations and internal company standards and values.
Key Responsibilities
(Scope will vary based on experience and level)
Identify opportunities and contribute to solutions for quality, process improvements, yield, efficiency, profitability, and compliance related to packaging processes.Implement packaging processes and technologies for new products and changes to existing packaging processes.Identify and implement packaging process improvements.Provide technical support to packaging areas for quality-related issues.Provide technical support to improve packaging line efficiency.Support audit readiness for regulatory inspections and ensure timely closure of commitments arising from audits.Develop and execute validation strategies for new packaging processes and configurations.Ensure timely completion of action items related to packaging technology transfer for consumer products.Identify and implement improvements in new processes, packaging configurations, and product launches.Actively participate in regulatory inspections.Education, Experience & Competencies
Bachelors Degree in Engineering (Industrial, Mechanical, or Electrical).1215 years of experience in the pharmaceutical industry.Supervisory experience or equivalent leadership exposure.Physical Demands
Work performed in both office and production floor environments.Ability to sit, stand, and walk for extended periods as required.May require moderate lifting.Ability to travel as needed.Equal Employment Opportunity (EEO) Statement
We are an Equal Opportunity Employer and are committed to creating an inclusive environment for all employees. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic in accordance with applicable federal and Puerto Rico laws. We encourage individuals from all backgrounds to apply.
Read LessPosition Overview
The Automation Specialist is responsible for executing automation initiatives that support clients operational efficiency and regulatory compliance. This role requirestechnical knowledge in PLC and HMI systems for manufacturing environments, with particular emphasis on packaging systems and operations. The ideal candidate will apply sound engineering principles to design, implement, and optimize automation solutions within cGMP-regulated environments, ensuring system reliability, performance, and compliance with industry standards.
Key Responsibilities
Qualifications
Bachelors degree in Engineering or a related technical discipline.Minimum of two (2) years of experience in industrial automation roles.Proven experience with PLC, SCADA, and standalone control systems in GMP-regulated environments.Basic project management knowledge, including scheduling, timeline tracking, and milestone coordination.Strong interpersonal and communication skills, with the ability to collaborate effectively across cross-functional teams.Self-motivated, organized, and capable of managing multiple priorities in a dynamic environment.Fully bilingual (English and Spanish), with strong written and verbal communication skills.Physical & Work Requirements
Ability to stand for extended periods during testing and execution activities.Willingness to work extended hours or shifts, based on project needs.Ability to climb ladders and lift up to 25 lbs.Must comply with gowning and PPE requirements in manufacturing and cleanroom environments, in accordance with GMP and OSHA standards.Equal Employment Opportunity (EEO) We are an equal opportunity employer committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.
Read LessJob Summary:
The Cleaning Validation Specialist will be responsible for developing, executing, and managing cleaning validation activities to ensure compliance with regulatory requirements and internal quality standards. The role focuses on ensuring the effectiveness and consistency of cleaning processes, particularly for manufacturing equipment and related systems, including utilities and compressed air systems. The ideal candidate will bring expertise in cleaning validation, utilities qualification, and a strong understanding of GMP regulations.
Responsibilities:
Develop and implement cleaning validation protocols and reports, ensuring compliance with GMP, FDA, and other regulatory standards.
Plan and execute cleaning validation activities for manufacturing equipment and utilities, including compressed air systems.
Conduct risk assessments and identify critical control points for cleaning validation.
Perform sampling and testing of cleaned equipment and utilities to ensure compliance with predetermined acceptance criteria.
Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to define cleaning validation requirements and processes.
Develop and implement protocols for utilities qualification and monitoring, with a focus on compressed air systems.
Analyze data to identify trends and recommend process improvements to enhance cleaning and utilities validation performance.
Manage deviations and non-conformances related to cleaning validation activities, ensuring timely investigation and resolution.
Maintain detailed and accurate documentation of cleaning validation and utilities qualification activities.
Ensure the consistent implementation of cleaning validation processes across manufacturing operations.
Support audits and inspections by regulatory authorities, providing expertise in cleaning validation and utilities processes.
Stay current with industry trends and regulatory updates, ensuring continuous compliance and the adoption of best practices.
Qualifications:
Bachelors Degree in Engineering, Chemistry, Microbiology, or a related field.
2+ years of experience in cleaning validation within a regulated manufacturing environment.
Experience in utilities qualification, particularly compressed air systems.
Strong knowledge of regulatory requirements, including GMP, FDA, and ICH guidelines.
Proficiency in developing and executing cleaning validation protocols and reports.
Demonstrated experience in risk assessment and data analysis for cleaning validation.
Excellent problem-solving and analytical skills.
Strong communication and interpersonal skills to collaborate with cross-functional teams and external auditors.
Proficiency in software tools such as MS Excel, Word, PowerPoint, and project management tools.
Physical/Mental Requirements:
Ability to work in a manufacturing environment, including cleanrooms and production areas.
Able to stand for extended periods and climb ladders/steps as needed.
Ability to lift and move items up to 25 lbs.
About the Company:
We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.
Want to be part of a transformative team? This job is for you!
Overview:
The CSV Account & Project Manager is responsible for managing client accounts, developing new business opportunities, and overseeing project execution for Moriahs services. This role combines technical project leadership with client service excellence, ensuring projects are delivered on time, on budget, and in compliance with all applicable standards, particularly in regulated industries such as pharmaceuticals and medical devices.
Responsibilities
Serve as primary point of contact for assigned clients, maintaining strong, long-term
relationships.
Identify areas of service (sales) opportunity & develop proposal.
Supervise, coach and lead the department team for overall projects and department
objectives.
Coordinate with Project Lead Coordinators to manage timelines, deliverables, and
resources.
Partner with upper management to develop strategies for business development
growth.
Identify areas of opportunity to expand services and support proposal development.
Act as technical consultant for automation and CSV solutions, providing strategic
recommendations to clients.
Lead and supervise cross-functional project teams in planning and execution.
Promote team engagement, accountability, and high performance throughout
project execution.
Conduct performance evaluations, one-on-one meetings, and approve PTO.
Ensure that all projects meet compliance standards (e.g., FDA, GMP) and client
expectations.
Maintain strong internal communication with operations and leadership teams.
Qualifications
Bachelors Degree Engineering, science or related field.
Ability to plan, manage and execute complex project activities to a successful
conclusion with little or no oversight.
5+ years of experience in engineering consulting, project management, or client
facing technical roles.
Proven experience in account management, sales, or consultative sales within
technical or regulated industries.
Experience with network and system administration of Microsoft based systems,
Visual Studio, ASP.Net and SQL is preferred.
Demonstrated successful communication and negotiation skills in order to manage
conflicting and/or multiple demands, including ability to present to various level
within an organization.
Demonstrated ability to apply analytical skills to identify problems; recognizes
symptoms, causes, and alternate solutions and makes timely sound decisions even
under risk and uncertainty.
Strong understanding of automation systems, PLCs, CSV, and related validation
frameworks.
Proven experience in CSV execution projects.
Proven track record in business development within the pharmaceutical or
regulated industries.
Skilled in managing multiple projects, teams, and priorities in parallel.
Proficiency in project management and CRM software.
Bilingual (Spanish and English) preferred.
Physical/Manufacturing Requirements
Office and plant environment.
Able to climb/ ladders/steps
Able to lift items 25 lbs
Keyboarding, lifting, standing, bending, walking.
Travel or Environment Requirements
Adhere to safe work practices
Some travel (including international) required (Approx. 5% of time)
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.
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