What are the responsibilities and job description for the Automation Project Manager position at Valspec?
Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.
Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.
Job Title: Automation Project Management Engineer
Job Description:
We are seeking an experienced Automation Project Management Engineer to manage the system integration for new production introduction to a Drug Substance Manufacturing (DSM) building. The equipment is primarily controlled by a DeltaV DCS, with potential updates to DeltaV MES and other integrated systems. This role will support equipment start-up and manage system integrator resources to complete commissioning, qualification, and initial engineering runs of DeltaV software.
Key Responsibilities:
- Coordinate project execution with the engineering design firm, CAPEX team, Automation process area owners, and system integrator.
- Manage the delivery of specification documents (e.g., platform requirements specification (PRS), functional specification (FS), design qualification (DQ), etc.) and test protocols (e.g., installation qualification (IQ), operational qualification (OQ), etc.).
- Initiate design and provide input on Automation requirements for one or multiple process areas.
- Oversee the System Integrator's support of loop checks and commissioning activities.
- Provide on-call support to Commissioning, Qualification, Validation, and Operations activities.
- Coordinate with various project workstreams including Automation, CSV, CQV, Utilities, Process Engineering, Manufacturing, and others as needed.
- Complete Safety, Project Procedure, and Project Instruction training as required.
Experience and Skills:
- Personal ownership and proactive collaboration with external business partners and internal stakeholders.
- Direct experience working with Emerson DeltaV DCS & DeltaV MES.
- Experience in a cGMP pharmaceutical facility working with FDA regulations is required.
- Working knowledge of Kneat validation software is required.
- Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively communicate within cross-functional teams and to management.
- Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels.
- Ability to manage commitments while displaying an eagerness to learn and continuously improve.
- Knowledge of Drug Substance Manufacturing (DSM) process.
- Experience with ComplianceWire, TrackWise, and Veeva is a plus.
Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.
Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.
Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.
Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
